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New Delhi, A <keyword id="15510" type="PERSON" weightage="20" keywordseo="Survey">survey</keyword> conducted by noted public health experts indicated that the side-effects post-vaccination, or '<keyword id="10759790" type="UNKNOWN" weightage="20" keywordseo="reactogenicity">reactogenicity</keyword>' in medical linguistic, is likely to occur in 66 per cent of the healthcare workers which are most probably to subside within a day of their onset. The survey, which compiled the responses from 5,396 <keyword id="6476236" type="UNKNOWN" weightage="20" keywordseo="respondents">respondents</keyword>, all healthcare professionals, who had received Covid vaccines, showed 66 per cent of them reported at least post-vaccination symptoms. The respondents in the survey stated that the most commonly reported symptoms they experienced after immunization were Myalgia (44 per cent), fever (34 per cent), headache (28 per cent), local pain at injection site (27 per cent), joint pain (12 per cent), nausea (8 per cent) and Diarrhoea (3 per cent) while tiredness (45 per cent) being the most prevailing one. "The occurrence of other symptoms such as <keyword id="51415" type="PERSON" weightage="20" keywordseo="Sore-throat">sore throat</keyword>, insomnia, giddiness rigor, allergic rash, chills, vomiting, syncope were reported 1 per cent or less," study said. It also noted that the symptoms reported by the respondents were not severe in nature or required hospitalisation. Besides, the survey also pointed out that in 90 per cent of the cases, the symptoms were either milder than expected or met the expectation of the vaccine recipient. Meanwhile, the survey illustrated that side effects among the most of the respondents did not last beyond the duration of 24 hours of the onset. "37 per cent (1,225) of the respondents revealed that their symptoms did not prolong more than a day while 31 per cent showed that their symptoms lingered for 48 hours, while only 6 per cent of claimed that their symptoms stretched beyond the duration of 48 hours," the survey showed. Speaking to IANS, Dr. Rajeev <keyword id="1073143" type="PERSON" weightage="20" keywordseo="Jayadevan">Jayadevan</keyword>, past president <keyword id="6365835" type="COMPANY" weightage="20" keywordseo="indian-medical-association">Indian Medical Association</keyword>, who is one of the researchers of the survey, said that one of the key takeaways from the survey is that vaccines are safe and there is no need to fear that it will harm ones' body. "If over 5,000 people who took it (vaccines) and reported no serious problem, then that is a considerable reassurance that the general public can take the vaccine," he reaffirmed. Another key finding of the survey was the linear correlation between age and post-vaccination symptoms suggested that the reactogenicity of the vaccine declined with age; means the chance of having symptoms decreased with advancing of age. The frequency of symptoms was found highest, 81.34 per cent , in respondents aged between 20-29 years followed by 30-39 years (79.57 per cent), 40-49 years (67.94 per cent), 50-59 years (58.23 per cent), 60-69 years (44.76 per cent), 70-79 years (33.73 per cent), and 80-89 years (7.43 per cent). Jayadevan said that younger people produce a lot of inflammatory cytokines which elicit reactogenicity (symptoms in layman terms) which is why they have vigorous response to the vaccines, whereas it is found lower in elder population. However, he added that the reactogenicity is not considered a reliable sign of producing antibodies. "There is a misconception among people and even healthcare professionals who believe that the reactogenicity is associated with development of antibodies. Everyone responds differently to the vaccines and elicit varied levels of reactogenicity depending upon age and other factors at play. It cannot be considered as a sign to determine that one's body is producing an immune response to the vaccines," Jayadevan explained. Dr. Ramesh Shenoy, another author of the survey, who is a senior radiologist at a hospital in Kochi, Kerala, said that the conclusions derived from the survey could be that the vaccines are safe while its side-effects are mild in nature and short lived. "The testimonies of the two third of the respondents vouch for it," he added. SEE ALSO: <a href="https://www.businessinsider.in/tech/mobile/news/comparison-between-realme-x7-pro-5g-and-xiaomi-mi-10i-mobile-phones-with-price-and-specifications/articleshow/80873224.cms">Realme X7 Pro 5G vs Xiaomi Mi 10i – best mid-range device under ₹30,000 in India</a> <a href="https://www.businessinsider.in/defense/news/experts-say-india-and-china-both-need-to-show-their-voters-that-they-won-in-ladakh-for-the-disengagement-to-be-successful/articleshow/80876036.cms">Experts say India and China both need to show their voters that they won in Ladakh⁠ for the disengagement to be successful</a> <a href="https://www.businessinsider.in/business/ecommerce/news/why-grofers-may-allow-an-american-blank-cheque-firm-to-buy-it-out-instead-of-fighting-ambani-and-bigbasket-for-ipo/articleshow/80874979.cms">Here’s why Grofers may allow an American “blank cheque” firm to buy it out instead of fighting Ambani and BigBasket for IPO</a>

66% healthcare workers report mild side-effects post COVID-19 vaccination, says survey

<keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>'s first indigenous vaccine against COVID-19, <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>, is safe and generates immune response without any serious side effects, according to the interim results of the phase 2 trials published in The <keyword id="6361830" type="COMPANY" weightage="20" keywordseo="lancet">Lancet</keyword> Infectious Diseases journal. The authors of the study noted that the phase 2 results did not asses the efficacy of the vaccine codenamed BBV152. Developed by <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> in collaboration with the Indian Council of Medical Research (ICMR) and the <keyword id="6375751" type="COMPANY" weightage="20" keywordseo="national-institute-of-virology">National Institute of Virology</keyword> (NIV), Pune, the vaccine has been granted emergency use authorisation in clinical trial mode by the Indian government. Covaxin had initially raised concerns among experts over its emergency approval by India's drug regulator. The latest study comes a week after Bharat Biotech announced that the vaccine has shown 81 per cent efficacy in the third phase of clinical trials, the results of which are yet to be published. The phase 2 trial to evaluate the immunogenicity and safety of BBV152 vaccine was conducted in healthy adults and adolescents aged 12-65 years at nine hospitals across nine states in India. Two intramuscular doses of vaccine were administered on day 0 and day 28. The primary outcome was assessed in all participants who had received both doses of the vaccine. Safety was assessed in participants who received at least one dose of the vaccine. Between September 5 and 12, last year, 921 potential participants were screened, 380 of whom were enrolled. "We report interim findings of the phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose on day 28," the authors of the study said. In the phase 1 trial, published in the same journal last month, BBV152 induced high neutralising antibody responses that remained elevated in all participants three months after the second vaccination. In the phase 2 trial, BBV152 showed better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses -- two main mechanisms within the adaptive immune system -- compared with the phase 1 trial. Adaptive immunity occurs after exposure to an antigen either from a pathogen or a vaccination. Reactogenicity refers to the property of a vaccine of being able to produce common, adverse reactions, especially excessive <keyword id="1441458" type="DOMAIN" weightage="20" keywordseo="immunological">immunological</keyword> responses and associated signs and symptoms, including fever and sore arm at the injection site. Covaxin is an inactivated vaccine developed by chemically treating novel coronavirus samples to make them incapable of reproduction. This process leaves the viral proteins, including the spike protein of the coronavirus, which it uses to enter the human cells, intact. Given as two doses, three weeks apart, the viral proteins in the vaccine activate the immune system and prepare people for future infections with the actual infectious virus. "The results reported in this study do not permit efficacy assessments. The evaluation of safety outcomes requires extensive phase 3 clinical trials," the authors of the Lancet study said. "We were unable to assess other immune responses in convalescent serum samples due to the low quantity," they said. Even though direct comparisons between the phase 1 and 2 trials cannot be made, the reactogenicity assessments reported in this study were substantially better in the phase 2 trial than the phase 1 trial and other trials with a placebo group, according to the authors. Also, the proportion of participants reporting adverse events in the phase 2 trial were lower than in the phase 1 trial, they noted. "This study enrolled a small number of participants aged 12-18 years and 55-65 years. Follow-on studies are required to establish immunogenicity in children and in those aged 65 years and older," the authors added. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/craftsman-automation-has-fixed-a-price-band-of-14881490-a-share-for-its-150-crore-ipo/articleshow/81408729.cms">Auto components maker Craftsman Automation’s ₹150 crore IPO to hit the capital markets next week — price band fixed at ₹1,488–1,490</a> <a href="https://www.businessinsider.in/india/news/india-is-using-the-quad-alliance-to-get-help-from-the-us-japan-and-australia-to-match-chinas-covid-19-vaccine-push/articleshow/81408044.cms">India is asking the QUAD for money to boost vaccine production and counter China’s moves on the global stage</a> <a href="https://www.businessinsider.in/business/corporates/news/elon-musks-net-worth-has-eroded-60-billion-in-just-two-months-as-teslas-market-cap-falls-35/articleshow/81407453.cms">Elon Musk’s wealth has eroded $60 billion in just two months as Tesla's market cap falls 35%</a>

Covaxin phase two data shows vaccine safe, induces immune response, says Lancet study

<keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s COVID-19 vaccine <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword> was on Tuesday recommended by an expert panel for <keyword id="6393270" type="UNKNOWN" weightage="20" keywordseo="phase">phase</keyword> II/III <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> on those aged between two to 18 years, official sources said. The trial will take place in 525 subjects at various sites, including <keyword id="40458" type="COMPANY" weightage="20" keywordseo="AIIMS">AIIMS</keyword>, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur. The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (<keyword id="6375144" type="COMPANY" weightage="20" keywordseo="cdsco">CDSCO</keyword>) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years. "After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source said. Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol. Covaxin, indigenously developed by Bharat Biotech in collaboration with the <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>n Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive. SEE ALSO: <a href="https://www.businessinsider.in/tech/apps/news/whatsapp-responds-to-privacy-criticism-by-alleging-other-apps-like-zomato-ola-aarogya-setu-zoom-google-and-other-apps/articleshow/82570897.cms">WhatsApp responds to privacy criticism by alleging that other apps and tech companies also show disdain for user privacy</a> <a href="https://www.businessinsider.in/business/telecom/news/vodafone-idea-adds-subscribers-for-the-first-time-in-15-months/articleshow/82568343.cms">Vodafone Idea shares up by 10% as it adds subscribers for the first time in 15 months – Airtel, Reliance Jio expand their user base</a>

Bharat Biotech's COVAXIN reportedly recommended by expert panel for phase 2 and 3 clinical trials on 2-18 year-olds

<ul class="summary-list"><li><keyword id="6409874" type="COMPANY" weightage="60" keywordseo="astrazeneca">AstraZeneca</keyword>'s <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword> <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword> triggers an immune response in elderly people as well as young adults, the drugmaker said Monday. </li><li>"Immunogenicity responses were similar between older and younger adults," an AstraZeneca spokesperson said.</li><li>The vaccine, being developed with the University of Oxford, is one of the world's leading COVID-19 vaccine candidates.</li><li>This does not necessarily mean the vaccine is safe and effective — but it is promising news, given that the immune system weakens as a person grows older.</li></ul>AstraZeneca's COVID-19 vaccine produces an immune response in elderly people, the drugmaker said on Monday.This does not necessarily mean the vaccine, being developed alongside the University of Oxford, is safe and effective in older people — but it is promising news, given that the immune system weakens as a person grows older.AstraZeneca also said "reactogenicity" — expected adverse reactions to the virus, which commonly include sore arm or swelling — was lower in older people than younger people.An AstraZeneca spokesperson told Business Insider: "It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher.""The results further build the body of evidence for the safety and immunogenicity of AZD1222," the name of the vaccine, the spokesperson added.The drugmakers' statement Monday came after the <a href="https://www.ft.com/content/b15446e5-66f7-4e6a-947a-1b638769ff79">the Financial Times</a> reported that the vaccine, one of the world's leading candidates, triggers protective antibodies and T-cells in older people, citing two people familiar with trial data. The findings came from blood tests carried out on a subset of older participants in the <keyword id="9237535" type="UNKNOWN" weightage="60" keywordseo="vaccine-trials">vaccine trials</keyword>. Details of the results are expected to be published in a clinical journal, the FT said.These results compare to data <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext">released in July</a> that showed the vaccine produced immune responses in a group of healthy adults between the ages of 18 and 55, the FT reported.The findings come after the Food and Drug Administration allowed <a href="https://www.businessinsider.com/astrazeneca-oxford-coronavirus-vaccine-trial-can-continue-in-the-us-2020-10?amp">AstraZeneca on Friday to resume its vaccine trials</a> in the US after a <a href="https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/">participant reported a "severe adverse reaction" on September 6</a>.<keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">Coronavirus</keyword> has killed more than 1.15 million people worldwide.With dozens of vaccine candidates in late-stage clinical trials, including AstraZeneca's, hope remains that a safe, effective vaccine will be developed before the end of the year.White House coronavirus advisor Dr. Anthony Fauci said in a <a href="https://www.bbc.co.uk/news/av/uk-politics-54680499" target="_blank" rel="noopener">BBC interview</a> on Sunday: "We will know whether a vaccine is safe and effective by the end of November, the beginning of December."Fauci added: "The question is: Once you have a safe and effective vaccine, or more than one, how can you get it to the people who need it as quickly as possible?"

AstraZeneca's COVID-19 vaccine produces an immune response in older people, raising hopes a vaccine will protect those at greatest risk

New Delhi, Jan 19 (IANS) Vaccine hesitancy amongst healthcare workers must end, medical expert and Niti Aayog member Dr V.K. Paul said on Tuesday, amidst heightened concerns over adverse events following immunisation and incomplete clinical trial data of Bharat Biotech's Covaxin. A total of 6.31 lakh people have been inoculated so far since the commencement of the vaccination drive on January 16. About 580 adverse events have been reported so far, out of which seven required hospitalisations. Two people died in Uttar Pradesh and Karnataka following vaccination, but their deaths are not related to the vaccine. "Vaccine hesitancy in health care workers must end. How will we fight the pndemic? Vaccine hesitancy must be extinguished before the pandemic extinguishes us," said Dr. Paul at a press conference. He said that serious problems related to the vaccine have been found to be negligible, unfounded, and insignificant. "We would like to assure you that these vaccines are safe and do not excite any undue reactogenicity and are being accepted increasingly." The rollout of Oxford's Covishield, manufactured by the Serum Institute of India, and Bharat Biotech's Covaxin began four days ago in the country amidst apprehensions about the safety of the latter. Covaxin is currently undergoing late-stage clinical trials, which are crucial to determining the efficacy of the shot. It has been in the spotlight of controversy ever since it received the green signal from the drug regulator for restricted emergency use. The approval without adequate efficacy data drew flak from public health advocacy groups, researchers, scientists, and activists. "The world is clamouring for the vaccine. Here, In India, the country made the vaccine, got them to the doorstep, and still if the healthcare workers are not taking it, it is saddening. I would request them to accept it. In the few days, we aim to vaccinate the healthcare workers and start the non-Covid facilities," Paul said. --IANS aka/vd

Vaccine hesitancy among healthcare workers must end: Govt

The <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> developed by teams at the University of Oxford has been shown to trigger a robust immune response in healthy adults aged 56-69 and those over 70 years of age. The findings published in 'Lancet' on Thursday based on 560 healthy adult volunteers shows that the ChAdOx1 nCoV-19 vaccine is "safe and well tolerated" with a lower reactogenicity profile in older adults than in younger adults, meaning the older age groups could build immunity to the disease. "These findings are encouraging because older individuals are at disproportionate risk of severe COVID-19 and so any vaccine adopted for use against SARS-CoV-2 [COVID-19] must be effective in older adults," the researchers note. The team is also testing whether the vaccine stops people developing COVID-19 in larger Phase 3 trials and early results from this crucial stage are expected in the coming weeks. "We were pleased to see that our vaccine was not only well tolerated in older adults, but also stimulated similar immune responses to those seen in younger volunteers," said Dr Maheshi Ramasamy, an investigator at the Oxford Vaccine Group. "The next step will be to see if this translates into protection from the disease itself," she said. This means there are now four promising vaccines on the horizon after Pfizer-BioNTech, Sputnik and Moderna already reporting good preliminary data from Phase 3 trials. The UK has already ordered 100 million doses of the Oxford vaccine, being manufactured by pharma major AstraZeneca. The vaccine also has a tie-up with the Serum Institute of India. SEE ALSO: <a href="https://www.businessinsider.in/business/corporates/news/wipro-ceo-delaportes-new-plan-could-allow-company-to-catch-up-to-to-tcs-infosys-hcl-tech-and-others/articleshow/79299467.cms">Wipro CEO Delaporte’s new plan could give the Indian IT services giant the edge it needs to catch up to its peers, according to analysts</a> <a href="https://www.businessinsider.in/india/news/spicejet-shares-gain-over-15-after-american-air-regulator-gives-boeings-737-max-clearance/articleshow/79299146.cms">SpiceJet shares gain over 15% after FAA Boeing’s 737 Max clearance — DGCA says will take some time before making a decision</a> <a href="https://www.businessinsider.in/business/startups/news/zomato-is-being-pulled-apart-in-a-polarised-india-for-pushing-advertising-money-to-backing-a-partisan-news-outfit/articleshow/79296969.cms">Zomato is being pulled apart in a polarised India⁠ for pushing advertising money to back a partisan news outfit</a>

Oxford University's COVID-19 vaccine shows safe results for senior citizens

<ul class="summary-list"><li>Most who've received boosters in the US have stuck with the brand of vaccine they got initially.</li><li>It's fine to switch it up. Some early studies suggest Moderna's jab is a bit stronger than Pfizer's.</li></ul>Now that free <a href="https://www.businessinsider.com/cdc-over-50-get-boosters-now-younger-adults-decide-2021-11">booster shots</a> are being offered to all adults in the US, many are wondering which is the best one to get.The truth is, <a href="https://www.businessinsider.com/cdc-jj-vaccine-doesnt-protect-as-well-as-moderna-pfizer-2021-10">all three authorized COVID-19 vaccines</a> do a good job, and you can decide to boost with whichever one you want. All three have been deemed <a href="https://www.businessinsider.com/jj-boosters-moderna-pfizer-provide-better-response-new-study-2021-10">safe and effective</a>.But there are some small differences in the vaccines that could be a factor in your decision — particularly for older adults, who may prefer the mRNA boosters, especially Moderna's, based on the available data.Moderna's vaccine <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7038e1.htm">tends to</a> prompt <a href="https://www.businessinsider.com/moderna-vaccines-might-not-need-boosters-like-pfizer-2021-9">slightly stronger immunity</a>, and it seems to elicit slightly higher antibody levels than the other two vaccines. That doesn't mean it's a dramatically better vaccine in the long run, but the extra protection it provides in the immediate term does seem to pass that of Pfizer, at least a little bit."To be honest, I'm not sure there's really a big difference between those two," Dr. William Moss, who directs the International Vaccine Access Center at Johns Hopkins University, said of Pfizer and Moderna, adding that he didn't see any strong argument for picking one mRNA vaccine over the other. "I would probably say, you know, whichever is more convenient to get." <h2>Most US adults have stuck with their original brand — except for J&amp;J users</h2>All adults are advised to get a <keyword id="11896085" type="UNKNOWN" weightage="60" keywordseo="booster-shot" source="Orion">booster shot</keyword> six months after their initial series — except for those who've gotten Johnson &amp; Johnson's single-shot vaccine. They have been advised to get a booster at any time two months after their initial shot. Federal data on booster shots suggests most people who got Moderna or Pfizer end up sticking with their initial brand when they get boosted.Johnson &amp; Johnson takers seem to have a slight preference for Moderna boosters. There <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01115-6/fulltext">is</a> <a href="https://www.businessinsider.com/jj-boosters-moderna-pfizer-provide-better-response-new-study-2021-10">evidence</a> to suggest that J&amp;J users might benefit from this "heterologous" boosting strategy — i.e., switching vaccine platforms — meaning they would add an mRNA vaccine (Pfizer or Moderna) on top of their adenovirus vaccine (J&amp;J). <div type="image" title="cdc chart showing what % of people who get each shot boost with the same shot." height="468" width="724" msid="88060172" hostid="261"></div><h2>Moderna's shot is a bigger dose than Pfizer's</h2>Moderna's booster is a half dose of the original vaccine, with 50 micrograms of mRNA in it. (Half-dose boosters are common for many vaccines, and they work well.)Pfizer's booster is the same size as the first two shots, with 30 micrograms of mRNA in it.Like Moderna's vaccine, Pfizer's ups antibody levels, meaning that people who get boosted with it <a href="https://www.businessinsider.com/chart-shows-how-fast-covid-booster-shot-protection-kicks-in-2021-11">reap the benefit of some increased protection</a> against infection for at least a few months afterward. (How long the extra protection lasts and how good it is are two things <a href="https://www.businessinsider.com/doctor-not-boosted-but-mom-is-getting-3rd-covid-shot-2021-11">scientists are still figuring out</a>.)<h2>Moderna's vaccine may be slightly more powerful than the others</h2>There is some emerging clinical data that suggests <a href="https://www.businessinsider.com/moderna-vaccines-might-not-need-boosters-like-pfizer-2021-9">Moderna's vaccine performs slightly better</a> at keeping older people out of the hospital.One <a href="https://www.research.va.gov/currents/1221-Which-COVID-19-vaccine-works-better.cfm">Veterans Affairs study</a> published on December 1 found that from January to May (before the emergence of the Delta variant) Moderna's vaccine was associated with a 21% lower risk of confirmed infection and a 41% lower risk of hospitalization than Pfizer's. In a more recent federally funded <a href="https://www.businessinsider.com/jj-boosters-moderna-pfizer-provide-better-response-new-study-2021-10">mix-and-match COVID-19-vaccine trial</a> of more than 450 adults, <a href="https://www.businessinsider.com/booster-vaccine-trial-mix-and-match-shots-pfizer-moderna-jandj-2021-6">Moderna's vaccine elicited</a> the most robust antibody responses post-boost, while Pfizer's was marginally lower and Johnson &amp; Johnson took third place. That's why <a href="https://www.scientificamerican.com/article/who-needs-a-covid-booster-shot-experts-answer-common-questions/">some experts say</a> it might be a better booster for older adults, who are generally more vulnerable to severe outcomes and need more frequent and potent boosters of all kinds.<h2>How the side effects differ</h2>Moderna boosters may be the most powerful, but they're also the most intense.Because Moderna's vaccine tends to be more reactogenic than Pfizer's, people who switch to Moderna for their booster may notice the severity of their <a href="https://www.businessinsider.com/booster-vaccine-trial-mix-and-match-shots-pfizer-moderna-jandj-2021-6">side effects</a> is a little higher than with their second shot. The most widespread complaint people have after either booster shot is some pain at the injection site. <a href="https://www.businessinsider.com/most-common-booster-shot-side-effects-include-headache-fever-cdc-2021-11">Headaches, fatigue, and muscle aches</a> are also common.For those who don't switch brands, getting a booster shot feels a lot like getting a second shot, whether it's from Pfizer or <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-19/03-COVID-Das-508.pdf">Moderna</a>.The one issue people in Moderna's clinical trial tended to complain of more often after their booster shots was some armpit swelling or tenderness. Pfizer trial recipients also reported a bit more swelling (lymphadenopathy) after their boosts.People who got Johnson &amp; Johnson's shot and stuck with the same brand for boosters <a href="https://www.fda.gov/media/152954/download#page=61">tended to report very similar, albeit slightly milder, side effects for a second shot</a> compared with their first. But all these adverse effects of booster shots are mild to moderate and temporary, usually not lasting for more than a day or two after vaccination. <h2>Many experts say it doesn't matter which booster you get</h2>With time, over the next several months and years, it will <a href="https://www.businessinsider.com/doctor-not-boosted-but-mom-is-getting-3rd-covid-shot-2021-11">become clearer which COVID-19-vaccination strategy is best</a>. In the meantime, infectious-disease experts say not to <a href="https://www.businessinsider.com/fauci-says-every-adult-should-get-booster-shot-when-eligible-2021-11">overthink it</a>. Regardless of which booster shot people choose, they are <a href="https://www.businessinsider.com/fauci-says-every-adult-should-get-booster-shot-when-eligible-2021-11">better protected against the virus</a> than people with just one (J&amp;J) or two (Pfizer or Moderna) shots. "Right now, don't make it complicated," Dr. Anthony Fauci, the nation's <a href="https://www.businessinsider.com/fauci-says-every-adult-should-get-booster-shot-when-eligible-2021-11">top infectious-diseases expert</a>, recently told Insider. "The effect of boost is very, very favorable to preventing people from getting infected."Th bottom line is: It's generally agreed (especially with the Omicron variant circulating) that it's reasonable for all adults to go ahead and get boosted with whichever shot they may choose to ahead of the holiday season.

How to choose which booster shot is right for you, between Pfizer and Moderna

Hyderabad, Sep 5 (IANS) The stage is set for phase II clinical trials of Bharat Biotech's coronavirus vaccine from Monday. The Hyderabad-based vaccine maker received the approval from Central Drugs Standard Control Organisation under the Directorate General of Health Services to conduct the phase II trials of indigenous vaccine candidate Covaxin. Joint Drugs Controller Dr S. Eswara Reddy wrote a letter to Bharat Biotech International, conveying the organisation's nod for conducting the phase II trials. These trials of the BBV152 coronavirus vaccine or Covaxin will be conducted on 380 participants, who will have to be screened for four days after they receive the vaccine shots. Through the letter, which IANS has seen, the Joint Drugs Controller said that the directorate had no objection to conducting the trial titled 'An adaptive, seamless Phase I, followed by Phase II randomized, double-blind, multicentre study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers'. The letter mentions that Bharat Biotech's request for approval to initiate phase II clinical trials was examined in consultation with Subject Expert Committee (COVID-19) experts held through virtual meeting on September 3. "This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on 03-09-2020, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised to 4 days," reads the letter dated September 3. Phase I clinical trials of the vaccine began on July 15 at 12 centres across the country where healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. These trials on 375 volunteers are still continuing. The subjects were monitored at the respective centres for two days after they were administered the vaccine shots. In the phase II clinical trials, this period has been revised to four days. Bharat Biotech had announced on June 29 that it had successfully developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The 'indigenous, inactivated vaccine candidate' has been developed and manufactured in Bharat Biotech's high containment facility located in Genome Valley, Hyderabad. Last month, SEC also approved Bharat Biotech's proposal to conduct trials using the intradermal (ID) vaccine delivery route. Under this route, the vaccine shot is given in the dermis, one of the layers of the skin. Experts say the shot is less invasive, requires lesser dosage and sometimes, helps the vaccine show better immune response. At the SEC meeting held on August 13, Bharat Biotech presented its proposal for the conduct of Phase I and II clinical trials of Covaxin by ID route. The SEC, while recommending approval, laid down the conditions that the trial sites should be different from the sites where the present clinical trials are going on for the vaccine through the intramuscular route and that the subject should be followed up for six months for clinical and antibody assessments. --IANS ms/ash

Stage is set for phase II trials of Bharat Biotech's COVID vaccine

New Delhi, Dec 12 (IANS) The representation of pediatric participants in the study population for the Pfizer-BioNTech Covid 19 vaccine is too limited to adequately evaluate efficacy in pediatric age groups younger than 16 years. As per data presented before the US FDA which approved the vaccine, the proceedings also looked at the unknown benefits and data gaps as per the FDA briefing document. Pfizer has told the US FDA that its plans for the vaccine clinical studies include boostability, dose ranging and studies in pediatrics, use in pregnancy, use in immunocompromised, refrigerator stable second-generation formulation and co-administration of influenza vaccine being considered. On the duration of protection, as the interim and final analyses have a limited length of follow-up, it is not possible to assess sustained efficacy over a period longer than 2 months. On the effectiveness in pediatric populations, the representation of pediatric participants in the study population is too limited to adequately evaluate efficacy in pediatric age groups younger than 16 years. No efficacy data are available from participants ages 15 years and younger. Although adolescents 16 to 17 years of age were included in the overall efficacy analysis, only one confirmed COVID-19 case was reported in this age group. "However, it is biologically reasonable to extrapolate that effectiveness in ages 16 to 17 years would be similar to effectiveness in younger adults," as per the FDA briefing document. Efficacy surveillance continued beyond November 14, 2020, and Pfizer has represented that additional data will be provided. On the vaccine effectiveness against asymptomatic infection, data are limited to assess the effect of the vaccine against asymptomatic infection as measured by detection of the virus and/or detection of antibodies against non-vaccine antigens that would indicate infection rather than an immune response induced by the vaccine. Additional evaluations will be needed to assess the effect of the vaccine in preventing asymptomatic infection, including data from clinical trials and from the vaccine's use post-authorization. Vaccine effectiveness against long-term effects of COVID-19 disease COVID-19 disease may have long-term effects on certain organs, and at present it is not possible to assess whether the vaccine will have an impact on specific long-term sequelae of COVID-19 disease in individuals who are infected despite vaccination. Demonstrated high efficacy against symptomatic COVID-19 should translate to overall prevention of COVID-19- related sequelae in vaccinated populations, though it is possible that asymptomatic infections may not be prevented as effectively as symptomatic infections and may be associated with sequelae that are either late-onset or undetected at the time of infection (e.g., myocarditis). Additional evaluations will be needed to assess the effect of the vaccine in preventing long-term effects of COVID-19, including data from clinical trials and from the vaccine's use postauthorization, the review said. On the effectiveness in individuals previously infected with SARS-CoV-2, the primary endpoint was evaluated in individuals without prior evidence of COVID-19 disease, and very few cases of confirmed COVID-19 occurred among participants with evidence of infection prior to vaccination (although more cases occurred in the placebo group compared with the vaccine group). "Therefore, available data are insufficient to make conclusions about benefit in individuals with prior SARS-CoV-2 infection. However, available data, while limited, do suggest that previously infected individuals can be at risk of COVID-19 (i.e., reinfection) and could benefit from vaccination", the review said. On the vaccine effectiveness against mortality, the review said a larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality. However, non-COVID vaccines (e.g., influenza) that are efficacious against disease have also been shown to prevent disease associated death. Benefits in preventing death should be evaluated in large observational studies following authorization, it said. Pfizer while seeking EUA for the vaccine told the US FDA that the vaccine is effective for the prevention of Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 16 years of age and older, no safety concerns identified in 43,448 subjects analyzed, no evidence of enhanced disease in vaccine recipients. The observed overall efficacy was 95 per cent, efficacious in younger and older adults, efficacious across diverse demographics and at-risk individuals and efficacious against severe disease. Pfizer said there is similar efficacy for key high-risk subgroups including the elderly and racial/ethnic minorities, reactogenicity profile and SAEs comparable to other licensed vaccines and extensive post-approval pharmacovigilance in place. Pfizer said timing is important to impact the pandemic as 55,000 US deaths per month could occur over the next few months and a Covid 19 vaccine can prevent many deaths. A pandemic vaccine must be introduced before the peak of cases to have maximal impact. A highly effective vaccine may be able to induce herd immunity, Pfizer said. (Sanjeev Sharma can be reached at sanjeev.s@ians.in) --IANS san/in

Representation of pediatrics too limited to evaluate efficacy for Pfizer vaccine

By Sudipto Chowdhury Kolkata, Jun 30 () Johnson &amp; Johnson is preparing the ground for the entry of a vaccine against COVID-19 and is expanding its manufacturing capacity to supply more than one billion doses through 2021 in a not-for-profit project aimed at the common person, says its top scientist. The US-based pharma giant, which has already advanced its schedule of starting human trials of its candidate vaccine to the second half of July from September, is working on the twin fronts of expanding existing manufacturing capacity and establishing new units, Chief Scientific Officer Paul Stoffels told . "We plan to begin production at risk and are committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use. We are expanding our global manufacturing capacity, including establishing new vaccine manufacturing capabilities," Stoffels said in an email interview from Belgium. "We are also scaling up capacities in other countries to further our goal to supply more than one billion doses of the vaccine globally through the course of 2021, provided the vaccine is safe and effective," he added. J&amp;J has joined hands with the US government for a $1 billion investment to speed up development and production of its vaccine. The company's efforts, part of the global race to develop a vaccine against COVID-19, comes as the pandemic continues its spread with more than 10 million cases and over 5,05,000 fatalities across the world. Explaining why the firm advanced its clinical trials by two months, Stoffels said, "Based on the strength of the preclinical data we have seen so far and after interacting with the regulatory authorities, we are able to accelerate the clinical development of our investigational SARS-CoV-2 vaccine candidate." The trials, which will begin in a fortnight, will be conducted in the US and Belgium on 1,045 healthy adults between the ages of 18 and 55 and adults who are 65 years and older. "From July 2020, the safety of the vaccine will be extensively tested in a small cohort of human volunteers. After the initial cohort it will be expanded to larger cohorts in a step-wise approach," Stoffels said. The company is in discussion with the National Institutes of Allergy and Infectious Diseases with an objective to start the Phase 3 clinical trial ahead of its original schedule, pending outcome of Phase 1/2a studies and approval of regulators, the Belgium-based scientist added. Stoffels, who is also vice chairperson of the executive committee of J&amp;J, said the lead vaccine candidate is a non-replicating viral-vector vaccine that contains a piece of DNA that codes for the coronavirus 'spike' protein. "Our aim for the vaccine candidate is that when a person receives the vaccine, their cells will make the spike protein, which is recognised by the immune system as foreign, stimulating production of antibodies and additional immune responses to fight off the virus. The process creates an immune memory, which ultimately teaches the body to both recognise and attack the virus," Stoffels elaborated. The company, he added, is partnering with health authorities and the world's best scientists to provide the safety and efficacy data necessary to support worldwide use of its SARS-CoV-2 vaccine candidate. Giving details of the trial, he said, "The randomised, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (adverse response to vaccination), and immunogenicity (beneficial immune response) of our investigational SARS-CoV-2 vaccine candidate." He described the pandemic as a challenge of global proportions requiring collaboration and support of governments around the world. Since January, J&amp;J has been working directly with governments and health authorities to help end this fast-moving COVID-19 pandemic. "J&amp;J has a long-standing commitment to address global health crisis and will continue to work closely with partners worldwide to combat the current COVID-19 pandemic through a multi-pronged approach… We will continue to bring our full resources and best scientific minds to combat this pandemic," Stoffels said. Vaccine development is a lengthy process which often takes years and has many challenges, explains E. Sreekumar, chief scientific officer at the Rajiv Gandhi Centre for Biotechnology (RGCB) in Kerala. Vaccine testing typically begins with animal and lab testing before going on to different stages of human testing. The human testing phase comprises many phases. Phase one trials are small-scale, usually involving few participants, to assess whether the vaccine is safe for humans. Phase two trials often involve several hundred subjects, and mainly evaluate the efficacy of the vaccine against the disease. The final phase involves thousands of people to further assess the efficacy of the vaccine over a defined period of time, and can last several months, Sreekumar said. SCH MIN MIN MIN

Human trials begin in fortnight, J&J works to ramp up production of affordable COVID vaccine: top scientist

<ul><li>Pfizer’s COVID-19 vaccine is over 90% effective, data from phase III trials show. </li><li>Eli Lilly receives approval from the US FDA for its COVID-19 antibody drug for use during emergency treatment. </li><li>Brazilian health regulator has suspended clinical trials of China’s Sinovac COVID-19 vaccine, citing an "adverse incident" involving a volunteer recipient. </li></ul>After registering over 48 million COVID-19 infections, the World Health Organisation is <a href="https://www.livemint.com/science/health/who-expects-to-see-covid-19-vaccine-by-end-of-2020-at-earliest-11602548070399.html">finally expecting</a> a COVID-19 vaccine by the end of 2020 or early 2021. It takes a decade or two to design, test, and launch an effective vaccine that can protect billions of people from diseases. However, COVID-19 has forced researchers to fast-track the vaccine making process. Here’s a look at COVID-19 vaccine updates from around the world — Pfizer’s COVID vaccine is 90% effective The latest data from t<a href="https://www.businessinsider.in/science/health/news/pfizers-covid-19-vaccine-is-90-effective-in-preventing-coronavirus-in-those-who-havent-been-infected-ever-before/articleshow/79130097.cms">he US pharmaceutical giant Pfizer</a> and German biotech firm BioNTech late-stage vaccine trial shows that their COVID-19 vaccine is <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against">90% more effective</a> in preventing infection if a person has never come in contact with it before. This means that those who get the vaccine will be protected within 28 days of the first dose — and there is only a two-dose schedule. Eli Lilly gets USFDA nod for COVID antibody drug in emergency use The US Food and Drug Administration (USFDA) on Monday has granted emergency approval to a synthetic <a href="https://www.bloombergquint.com/onweb/eli-lilly-covid-19-antibody-therapy-gets-emergency-fda-clearance">antibody treatment against COVID-19 developed by Eli Lilly</a>. The drug was shown to reduce the risk of hospitalization and emergency room visits. The drug, Bamlanivimab, is the first major drug to be approved that was designed specifically against the coronavirus. Brazil suspends trial of Chinese COVID vaccine The Brazilian health regulator Anvisa on Monday suspended <a href="https://www.channelnewsasia.com/news/world/brazil-china-sinovac-covid-19-vaccine-trial-adverse-effect-13506350">clinical trials of China’s Sinovac COVID-19 vaccine</a>, citing an "adverse incident" involving a volunteer recipient. Anvisa in a statement referred to the "incident" that occurred on October 29 and did not reveal any further information. Argentina is looking to have access to COVID vaccine by December Argentina is looking to have possession of a COVID vaccine by December. The government said it would first administer it to the most vulnerable section of the population in the country. "We are making progress in signing the contractual agreements to make it so," the chief of the cabinet of ministers, Santiago Cafiero said on Saturday, confirming that the government wants "to have commercial agreements with countries, like Russia, or with laboratories, like Pfizer and AstraZeneca." Bharat Biotech likely to launch Covaxin in February According to a <a href="https://in.reuters.com/article/health-coronavirus-india-vaccine/exclusive-india-made-covid-19-vaccine-could-be-launched-as-early-as-february-government-scientist-idINKBN27L0WU">Reuters report</a>, Bharat Biotech COVAXIN could be launched as early as February - months earlier than expected - as last-stage trials begin this month and studies have so far shown it is safe and effective. Bharat Biotech, which is developing COVAXIN with the government-run Indian Council of Medical Research (ICMR), had earlier hoped to launch it only in the second quarter of next year. Astrazeneca is likely to begin COVID-19 vaccine trials in China AstraZeneca <a href="https://www.reuters.com/article/health-coronavirus-astrazeneca-china-idUSKBN27M0F9?taid=5fa503af260cc00001474375&amp;utm_campaign=trueAnthem:+Trending+Content&amp;utm_medium=trueAnthem&amp;utm_source=twitter">plans to start early and mid-stage clinical trials of its COVID-19 vaccine candidate in China </a>this year, a senior executive told Reuters. The vaccine trials are in its final stage in the US, UK, and other countries. AstraZeneca is developing this along with the University of Oxford, and it hopes to find data of its effectiveness from the late-stage trials by the end of this year. Adar Poonawalla says Oxford vaccine trial results likely next month The chief executive <a href="https://www.timesnownews.com/health/article/adar-poonawalla-says-india-may-get-a-covid-19-vaccine-by-jan-oxford-trial-results-likely-next-month/677545">officer of Serum Institute of India, Adar Poonawalla</a>, said that a safe and effective vaccine against the novel coronavirus might be available in the country by January next year. The Pune-based firm, which is testing and manufacturing Oxford’s Covishield vaccine in India, said if trials succeed and approvals from regulatory bodies are in place, the vaccine will be ready in time. Brazilian health regulator allows Johnson &amp; Johnson to resume trials In another development, the Brazilian health regulator Anvisa has approved the resumption of human clinical trials for Johnson &amp; Johnson’s COVID-19 vaccine. The J&amp;J vaccine is one of the four being tested in Brazil — which has the world’s third-worst outbreak behind the United States and India. CanSino Biologics delivers Covid-19 vaccine to Mexico for a late-stage trial Mexico has <a href="https://www.reuters.com/article/health-coronavirus-mexico-vaccine-idUSKBN27J21V">received </a>the first doses of a COVID-19 vaccine from Chinese pharmaceutical company CanSino Biologics Inc. for a late stage-trial on between 10,000 and 15,000 volunteers. Germany CureVac's vaccine triggers an immune response On Monday, German vaccine maker CureVac said that interim results from early trials showed that its investigational Covid-19 vaccine candidate, CvnCoV, appeared safe and triggered immune response among volunteers. "We are very encouraged by the interim Phase 1 data. It represents a critical milestone in our Covid-19 vaccine programme and strongly supports the advancement of our vaccine candidate," Franz-Werner Haas, Chief Executive Officer of CureVac, said in a statement. Aspen Pharmacare, Johnson &amp; Johnson announce a deal to make Covid-19 vaccine South African pharmaceutical giant Aspen Pharmacare signed a pact with Johnson &amp; Johnson to manufacture its Covid-19 vaccine if approved in South Africa and internationally. In a statement, Aspen said that if ongoing trials bring international health authorities to endorse the J&amp;J vaccine as effective and safe, it would be produced at Aspen's manufacturing facility in Port Elizabeth in South Africa's Eastern Cape province. Moderna prepares for the global launch of COVID-19 vaccine American biotechnology company Moderna announced that it was preparing for the global launch of its Covid-19 vaccine candidate. "We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world," Xinhua news agency quoted Moderna CEO Stephane Bancel as saying in a statement on Thursday. In addition to the Phase 3 study of the Covid-19 vaccine mRNA-1273, which is fully enrolled, Moderna now has four programs in Phase 2 studies, according to Bancel. Israel begins human trials of COVID vaccine Israel has begun <a href="https://www.businessinsider.in/science/health/news/israel-begins-human-trials-on-covid-19-vaccine/articleshow/78991044.cms?upcache=2">human trials</a> of a COVID-19 vaccine on November 1, authorities have said. Two volunteers have received the vaccine. Israel will first test the vaccine on 80 people, before extending it to 980 in the second phase, and then 25,000 in the final stage, slated for April or May. "We can see the light at the end of the tunnel," Prime Minister Benjamin Netanyahu told reporters at Sheba Medical Center near Tel Aviv. Japan’s Shionogi is planning to conduct clinical trials of COVID-19 vaccine in December Japan’s Shionogi is planning to conduct phase I clinical trials of its COVID-19 vaccine candidate in December and phase II trials in January. Moreover, Shionogi S phase III trials are likely to be done overseas “due to the relative lack of COVID-19 cases in Japan”, reported Reuters. Brazil says it might get a COVID-19 vaccine by June 2021 Brazil is expected to have a COVID-19 vaccine <a href="https://zeenews.india.com/world/brazil-will-have-a-covid-19-vaccine-by-june-2021-says-regulator-2321092.html">ready </a>by June next year, according to the head of Brazil’s health regulator Anvisa, Antonio Barra Torres. According to Reuters, Anvisa is yet to decide on the minimum efficacy required to give vaccine approval. However, the agency has approved the vaccine with less than 50% effectiveness previously. Brazil has played a significant role in conducting late-stage clinical trials of many global vaccine candidates including Oxford-AstraZeneca. Oxford-AstraZeneca’s COVID-19 vaccine triggers an immune response in both young and old adults Oxford-AstraZeneca’s COVID-19 vaccine candidate has <a href="https://in.reuters.com/article/health-coronavirus-astrazeneca-vaccine-i/oxford-covid-19-vaccine-prompts-immune-response-among-adults-old-and-young-astrazeneca-says-idUSKBN27B0L7">prompted </a>an immune response in both young and old adults. According to AstraZeneca, the vaccine also produces ‘lower adverse responses among elderly,” reported Reuters. “It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman said. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/pfizers-covid-19-vaccine-is-90-effective-in-preventing-coronavirus-in-those-who-havent-been-infected-ever-before/articleshow/79130097.cms" data-type="tilCustomLink">Pfizer’s COVID-19 vaccine is 90% effective in preventing coronavirus in those who haven’t been infected ever before, shows data from latest trials</a> <a href="https://www.businessinsider.in/business/auto/news/mm-q2-earnings-tomorrow-profit-likely-to-fall-19-percent-but-tractor-sales-may-help-revenue/articleshow/79129620.cms" data-type="tilCustomLink">Strong tractor sales may cushion M&amp;M’s revenue but profit is likely to remain under pressure, say analysts</a>

COVID-19 vaccine tracker: Pfizer says COVID-19 vaccine over 90% effective, Eli Lilly’s antibody drug therapy gets FDA nod for emergency use, Brazil suspends trial of Chinese coronavirus vaccine

<ul><li>German vaccine maker CureVac said that interim results from early trials showed CvnCoV triggered immune response among volunteers. </li><li>Israel began <a href="https://www.businessinsider.in/science/health/news/israel-begins-human-trials-on-covid-19-vaccine/articleshow/78991044.cms?upcache=2">human trials</a> of a COVID-19 vaccine on November 1. </li><li>South African pharmaceutical giant Aspen Pharmacare signed a pact with Johnson &amp; Johnson to manufacture its Covid-19 vaccine.</li></ul>After registering over 42 million COVID-19 infections, the World Health Organisation is <a href="https://www.livemint.com/science/health/who-expects-to-see-covid-19-vaccine-by-end-of-2020-at-earliest-11602548070399.html">finally expecting</a> a COVID-19 vaccine by the end of 2020 or early 2021. It takes a decade or two to design, test, and launch an effective vaccine that can protect billions of people from diseases. However, COVID-19 has forced researchers to fast-track the vaccine making process. Here's a look at COVID-19 vaccine updates from around the world — Bharat Biotech to launch Covaxin by mid-2021 Bharat Biotech is planning to launch India's indigenous COVID vaccine, Covaxin, in the second quarter of next year, after it gets the necessary approvals from regulatory authorities, reported <a href="https://in.reuters.com/article/health-coronavirus-india-vaccine/bharat-biotech-plans-to-launch-vaccine-candidate-in-second-quarter-of-2021-idINKBN27H1JG">Reuters</a>. The company is planning to begin recruitment for the third phase of its vaccine trials this month. The trial will be conducted in 25 sites in 10-12 states and will provide two doses with each for the vaccine and placebo recipients, the company's Executive Director Sai Prasad said. Germany CureVac's vaccine triggers an immune response On Monday, German vaccine maker CureVac said that interim results from early trials showed that its investigational Covid-19 vaccine candidate, CvnCoV, appeared safe and triggered immune response among volunteers. "We are very encouraged by the interim Phase 1 data. It represents a critical milestone in our Covid-19 vaccine programme and strongly supports the advancement of our vaccine candidate," Franz-Werner Haas, Chief Executive Officer of CureVac, said in a statement. Aspen Pharmacare, Johnson &amp; Johnson announce a deal to make Covid-19 vaccine South African pharmaceutical giant Aspen Pharmacare signed a pact with Johnson &amp; Johnson to manufacture its Covid-19 vaccine if approved in South Africa and internationally. In a statement, Aspen said that if ongoing trials bring international health authorities to endorse the J&amp;J vaccine as effective and safe, it would be produced at Aspen's manufacturing facility in Port Elizabeth in South Africa's Eastern Cape province. Moderna prepares for the global launch of COVID-19 vaccine American biotechnology company Moderna announced that it was preparing for the global launch of its Covid-19 vaccine candidate. "We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world," Xinhua news agency quoted Moderna CEO Stephane Bancel as saying in a statement on Thursday. In addition to the Phase 3 study of the Covid-19 vaccine mRNA-1273, which is fully enrolled, Moderna now has four programs in Phase 2 studies, according to Bancel. Israel begins human trials of COVID vaccine Israel has begun <a href="https://www.businessinsider.in/science/health/news/israel-begins-human-trials-on-covid-19-vaccine/articleshow/78991044.cms?upcache=2">human trials</a> of a COVID-19 vaccine on November 1, authorities have said. Two volunteers have received the vaccine. Israel will first test the vaccine on 80 people, before extending it to 980 in the second phase, and then 25,000 in the final stage, slated for April or May. "We can see the light at the end of the tunnel," Prime Minister Benjamin Netanyahu told reporters at Sheba Medical Center near Tel Aviv. Japan’s Shionogi is planning to conduct clinical trials of COVID-19 vaccine in December Japan’s Shionogi is planning to conduct phase I clinical trials of its COVID-19 vaccine candidate in December and phase II trials in January. Moreover, Shionogi S phase III trials are likely to be done overseas “due to the relative lack of COVID-19 cases in Japan”, reported Reuters. Brazil says it might get a COVID-19 vaccine by June 2021 Brazil is expected to have a COVID-19 vaccine <a href="https://zeenews.india.com/world/brazil-will-have-a-covid-19-vaccine-by-june-2021-says-regulator-2321092.html">ready </a>by June next year, according to the head of Brazil’s health regulator Anvisa, Antonio Barra Torres. According to Reuters, Anvisa is yet to decide on the minimum efficacy required to give vaccine approval. However, the agency has approved the vaccine with less than 50% effectiveness previously. Brazil has played a significant role in conducting late-stage clinical trials of many global vaccine candidates including Oxford-AstraZeneca. Oxford-AstraZeneca’s COVID-19 vaccine triggers an immune response in both young and old adults. Oxford-AstraZeneca’s COVID-19 vaccine candidate has <a href="https://in.reuters.com/article/health-coronavirus-astrazeneca-vaccine-i/oxford-covid-19-vaccine-prompts-immune-response-among-adults-old-and-young-astrazeneca-says-idUSKBN27B0L7">prompted </a>an immune response in both young and old adults. According to AstraZeneca, the vaccine also produces ‘lower adverse responses among elderly,” reported Reuters. “It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman said. Pfizer recruits 42,000 volunteers for phase II and III clinical trials. US drugmaker Pfizer — which is working on a COVID-19 vaccine with German pharma company BioNTech — has <a href="https://www.indiatoday.in/coronavirus-outbreak/story/coronavirus-vaccine-update-oxford-astrazeneca-vaccine-immune-response-pfizer-covaxin-news-1735407-2020-10-27">recruited </a>42,111 volunteers to test its experimental COVID-19 vaccine candidate. Earlier this week, Pfizer said it is likely to submit its COVID-19 vaccine to the Food and Drug Administration (FDA) approval in November if the trials are successful. Joe Biden pledges free COVID-19 vaccines for all Americans if elected. Democratic presidential nominee Joe Biden, on October 24, has said that if he is elected to power in the November 3 election, he will make COVID-19 vaccines free for all Americans. "Once we have a safe and effective vaccine, it has to be free to everyone -- whether or not you're insured," Xinhua news agency quoted Biden as saying during a speech in Wilmington, Delaware. Johnson &amp; Johnson pauses late-stage COVID-19 trials following a participant’s illness A late-stage study of Johnson &amp; Johnson's COVID-19 vaccine candidate has been paused while the company investigates whether a study participant's unexplained illness is related to the shot. In a statement, the company said that illnesses, accidents and other so-called adverse events are an expected part of any clinical study, especially large studies, but that its physicians and a safety monitoring panel would try to determine what might have caused the illness. The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the US. The company declined to reveal any more details about the illness, citing the participant's privacy. Russia’s COVID-19 vaccine to be widely domestically available by early November Russia is all set to launch its COVID-19 vaccine, Sputnik V, domestically by late October or early November, according to the Russian Direct Investment Fund (RDIF). Earlier in August, Russia claimed to be the first country to develop a <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword>. "We believe that the vaccine can start being widely used in Russia by late October or early November," Kirill Dmitriev, head, RDIF said. It is further expecting to roll out the vaccine in the Middle-East after human trials by the end of November, <a href="https://tass.com/society/1211423">Russian news agency TASS reported. </a> Pakistan hopes to acquire a COVID-19 vaccine within the next 6 months A Pakistani official from the Ministry of National Health Services has expressed hope that the country would acquire a vaccine against the novel coronavirus in the next six months. The official said on October 12 that Pakistan has also prepared antibodies against spike proteins, <a href="https://www.dawn.com/news/1584505/covid-positivity-rate-crosses-2pc-first-time-in-six-weeks">Dawn reported.</a> "At present, 15 vaccines were in phase-III trials globally out of which 11 target the spike protein," he said. UK to begin trials to test if anti-TB BCG vaccine works against COVID-19 Scientists in the United Kingdom will begin recruiting frontline healthcare workers to test if an old vaccine used to combat tuberculosis (TB), the Bacillus Calmette-Guerin, or BCG jab can be repurposed to help boost immunity against the novel coronavirus as well. The University of Exeter in south-west England said on October 11 that it is leading the UK arm of the worldwide research called the BCG vaccination to reduce the impact of COVID-19 in healthcare workers (BRACE) trials. Participants will be given either the BCG vaccine, currently provided to more than 100 million babies worldwide each year, including in India, to protect against TB or a placebo injection. In India, Bharat Biotech asked to submit complete phase 2 trial data of its COVID-19 vaccine before phase 3 trials On October 10, Bharat Biotech — which earlier got permission to conduct phase-3 clinical trials of its COVID-19 vaccine candidate — has been asked to submit complete safety and immunogenicity data of the ongoing phase-2 trial, besides providing some clarifications, before proceeding for the next stage. The vaccine candidate, 'Covaxin,' is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). According to officials, the Hyderabad-based vaccine maker applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission to conduct phase III randomised, double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate. SEE ALSO:<a href="https://www.businessinsider.in/thelife/personalities/news/prajakta-koli-aka-mostlysane-advice-for-content-creators-on-the-fine-line-between-brand-collaborations-and-staying-honest-on-social-media/articleshow/79013162.cms" data-type="tilCustomLink"> Prajakta Koli aka MostlySane’s advice for content creators on the fine line between brand collaborations and staying honest on social media</a> <a href="https://www.businessinsider.in/stock-market/news/top-stock-movers-tata-motors-zee-entertainment-icici-bank-cadila-healthcare-sterlite-technologies-and-others/articleshow/79012842.cms" data-type="tilCustomLink">Top stock movers — Tata Motors, Zee Entertainment, ICICI Bank, Cadila Healthcare, Sterlite Technologies and others</a> <a href="https://www.businessinsider.in/international/news/india-hits-out-at-pakistan-for-taking-advantage-of-coronavirus-pandemic-to-enhance-cross-border-terrorism/articleshow/79013307.cms" data-type="tilCustomLink">India hits out at Pakistan for taking advantage of coronavirus pandemic to enhance cross-border terrorism</a>

You Searched For "reactogenicity" and got 12 results

66% healthcare workers report mild side-effects post COVID-19 vaccination, says survey

IANS

Covaxin phase two data shows vaccine safe, induces immune response, says Lancet study

PTI

Bharat Biotech's COVAXIN reportedly recommended by expert panel for phase 2 and 3 clinical trials on 2-18 year-olds

PTI

AstraZeneca's COVID-19 vaccine produces an immune response in older people, raising hopes a vaccine will protect those at greatest risk

Kate Duffy

Vaccine hesitancy among healthcare workers must end: Govt

IANS

Oxford University's COVID-19 vaccine shows safe results for senior citizens

PTI

How to choose which booster shot is right for you, between Pfizer and Moderna

Hilary Brueck

Stage is set for phase II trials of Bharat Biotech's COVID vaccine

IANS

Representation of pediatrics too limited to evaluate efficacy for Pfizer vaccine

IANS

Human trials begin in fortnight, J&J works to ramp up production of affordable COVID vaccine: top scientist

PTI

COVID-19 vaccine tracker: Pfizer says COVID-19 vaccine over 90% effective, Eli Lilly’s antibody drug therapy gets FDA nod for emergency use, Brazil suspends trial of Chinese coronavirus vaccine

BI India Bureau

COVID-19 vaccine tracker: German CureVac shows an immune response, Aspen Pharmacare and J&J sign pact to make vaccine in South Africa

BI India Bureau

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