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The FDA is preparing to authorize Pfizer's vaccine

Dec 11, 2020, 22:50 IST
Business Insider
Hollis Johnson/Business Insider

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Hello,

What a week it's been. If you had any doubts this month could be one long marathon of vaccine news, this week certainly proved the case.

In the last week alone, we saw the peer-review publication of data on both AstraZeneca/Oxford and Pfizer/BioNTech's shots.

We got detailed looks at the safety and efficacy of Pfizer/BioNTech's vaccine via documents released Tuesday by the Food and Drug Administration.

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We got a full-day meeting with an influential expert panel, that voted to recommend Pfizer and BioNTech's shots.

And the FDA said Friday that it plans to authorize the vaccine (though it hasn't officially done so yet).

... And we get to do it all again when the FDA reviews Moderna's vaccine next week. Our reporters Andrew Dunn and Hilary Brueck have been covering every development, so be sure to follow along with them for more updates this weekend and beyond.

We'll be here to let you know when the authorization is officially official. Be sure to subscribe to this newsletter here, if you haven't already.

A nurse prepares to inject staff with the Pfizer/BioNtech covid-19 vaccine at Bradley Manor residential care home in Belfast on December 9, 2020.Liam McBurney/PA Images via Getty Images

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Pfizer's vaccine could get emergency authorization at any moment

It was a big week for Pfizer and its partner BioNTech.

On Thursday, the FDA convened its expert advisory panel to discuss a key question: whether the benefits of the vaccine outweigh the risks for Americans 16 and up.

Helping them make that decision was a whole set of documents detailing the safety and efficacy of the vaccine, first published Tuesday.

Meanwhile, across the pond, the UK on Tuesday began dosing the first patients with the vaccine, starting with a 90-year-old grandmother with what has to be the best penguin shirt I've seen.

Relatedly, Dr. Catherine Schuster-Bruce reports on how Qdoctor, a little-known telehealth startup, is poised to make a mark by helping the UK roll out the vaccine.

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Notably, as people outside of clinical trials started getting vaccinated, two people with known allergies had allergic reactions after receiving Pfizer's shot. Both are fine, but it prompted the UK to issue a warning that people with severe allergies should avoid getting Pfizer's vaccine.

While we still don't have a full picture of what's going on with the allergic reactions (they didn't show up in clinical trials conducted by Pfizer and BioNTech), Hilary has the breakdown of what all is in the vaccine - including sucrose.

The topic of allergic reactions was one of many that came up in the course of Thursday's advisory committee meeting. Ultimately, the panel voted 17-4, with one abstention, to recommend the authorization of Pfizer/BioNTech's vaccine.

A concern that came up among some of the "no" votes: the question asked the experts whether they'd approve the shot for Americans 16 and up. Some expressed concerns with including 16 and 17-year-olds, but a push to change the wording on the question to keep it 18 and up didn't pan out.

Now, it's up to the FDA to make a decision, one that could come shortly.

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Here's the latest>>

The FDA says it will authorize Pfizer's COVID-19 vaccine, paving the way for people in the US to start getting shots as early as Monday

Erin Clark/The Boston Globe via Getty Images

All eyes turn to vaccine rollout and manufacturing

With a full picture of the safety and efficacy of Pfizer/BioNTech's vaccine (with Moderna up next), questions around distribution and manufacturing are popping up.

Allana Akhtar and Shelby Livingston teamed up to get an inside look on how hospitals are planning to distribute vaccines to their frontline workers. With limited supply, it leaves tough decisions about who to vaccinate first.

Notably, how the vaccine rolls out in hospitals will inform how those institutions then prepare to vaccinate the public over the next year.

Read the full story here: 'This is game time': Hospitals across the country are gearing up to give the first COVID-19 shots to millions of healthcare workers

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Another place getting the first batch of doses of vaccines: long-term care facilities.

Shelby spoke with the chief medical officer of Genesis, the biggest nursing-home chain in the US. He sounded off about a potentially messy COVID-19 vaccine rollout because of a patchwork of state vaccination plans.

Retail pharmacy giants CVS Health and Walgreens are involved in the federal plans to administer vaccines at nursing homes. But some states like West Virginia are forming their own plans that don't rely on the pharmacy giants, Shelby reports.

Making sure there's a steady supply of vaccine doses will be no easy feat either, especially for Moderna, a company that has yet to produce an approved medicine.

Andrew took a closer look at Moderna's plans - that involve a former Polaroid factory - to get a sense of how they'll manage to pump out up to 1 billion vaccine doses.

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Read the full story here>>

Moderna's ambitions of pumping out up to 1 billion doses of a coronavirus vaccine rest on a former Polaroid factory that's never produced an approved drug

Dr. Ugur Sahin and Dr. Özlem Türeci.Stefan F. So¤mmer via www.imago-images.de/Reuters

The people responsible for getting vaccines across the finish line

Sometimes I think about how remarkable it is that we're hearing about safe and effective vaccines on the cusp of approval roughly a year after the virus emerged. After years of watching drug development take years to pull off, it's certainly a feat a lot of people deserve a lot of credit for.

Among those is scientist Katalin Karikó, who's spent her career trying to convince her colleagues that messenger RNA could be used to fight diseases in humans. (Both Pfizer and Moderna's vaccines rely on mRNA, as you likely know by this point.)

Aria Bendix reports on her life and career here: Scientist Katalin Karikó risked her career in pursuit of mRNA vaccines. Her achievement could rescue the world from the pandemic.

Andrew, Kimberly Leonard, and I rounded up some of the leaders, executives, and scientists that have had major hands in getting coronavirus vaccines across the finish line.

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You can read the full list here>>

Meet the 19 key scientists, executives, and leaders responsible for pushing coronavirus vaccines across the finish line

Collective Medical's cofounders Wylie van den Akker, Chris Klomp, and Adam Green.Collective Medical

Funding rounds, SPAC IPOs, and acquisition scoops

OK, now for a brief break from vaccine-land.

Healthcare startups are still bringing in more cash through the end of the year - and sky-high valuations along with it.

Younger companies, too, are securing early investments.

Megan Hernbroth spoke to Tom Stanis, a former Verily executive who left the company in February.

The Verily cofounder's experience coordinating doctors after his dad's stroke inspired his new company, Story Health. It's addressing one of the most overlooked parts of caring for patients.

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Some are turning to the public markets for more cash. That includes three-year-old, $1.6 billion Hims.

Megan dug through Hims' financials and spoke to its CEO to find 4 key metrics that could determine the company's success.

Other venture-backed companies are getting acquired to close out the year.

Blake Dodge on Monday had the scoop on a deal struck by health-tech company PointClickCare, which is acquiring Collective Medical for $650 million.

Read the full story here>>

SCOOP: PointClickCare is buying a Kleiner Perkins-backed startup for $650 million in the latest sign that health-tech is heating up

I'll likely be online a lot of this weekend waiting for official word on authorization. What questions do you have about what's ahead? Have you already scheduled your time to get a shot? I want to hear about it all!

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Reach me at lramsey@businessinsider.com, or you can reach our entire team at healthcare@businessinsider.com.

Also - Our advertising and media team is looking for input from PR professionals to help shape Business Insider's coverage of the PR industry over the next year. Please take our (anonymous) survey here and tell us what we should be writing about in 2021.

- Lydia

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