AstraZeneca 'scoronavirus vaccine faces a murky future in the US, where three other shots are already in use.- Public-health experts said the two-dose vaccine should secure an emergency OK from US regulators.
- Despite that OK, the US may end up giving its AstraZeneca supply to other countries, they said.
Dr. Ashish Jha, a top US public-health expert, earlier this month laid out what he thought was an unpopular opinion.
Shortly after AstraZeneca announced that its
"The time to use AZ here would have been in January," he wrote on Twitter. "By May, we won't need it."
Now, Jha's unpopular opinion has gained momentum, even as experts anticipate the vaccine will soon secure US emergency authorization.
There are two main reasons the vaccine experts said the shot from AstraZeneca and Oxford University won't be used much in the US, if at all. For one, it's likely to be authorized after most US adults have gotten a vaccine made by another company. And there isn't a good argument to be made that it's at least as good as the three shots already in use in this country.
"If there is a choice and if we have enough doses of the other three vaccines, then the argument for incorporating AstraZeneca is slim to none in US vaccine distribution," Josh Michaud, associate director of global
US government leaders haven't said what they plan to do if AstraZeneca's shot is authorized, but appear to be considering not rolling out the shot.
"That's still up in the air," Dr. Anthony Fauci, the nation's top infectious-disease expert, told Reuters on April 1. "My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca."
The vaccine still has a critical role to play on the world stage. It's one of the only vaccines, alongside shots developed in Russia and China, where substantial amounts have been delivered to low- and middle-income countries, said Maria Elena Bottazzi, a vaccine developer and associate dean of Baylor University's National School of Tropical Medicine. From the start, AstraZeneca has sold its shot at no-profit pricing at $3 to $4 per dose - far cheaper than other vaccine developers.
That leaves the US in a curious position, because the government signed a deal with AstraZeneca last summer to eventually deliver 300 million doses of the shot.
Bottazzi said the US should donate those doses to Covax, the World Health Organization's vaccine procurement effort for lower-income countries.
A history of controversies and late-to-market timing don't help chances in the US
Experts highlighted two challenges impeding AstraZeneca's US rollout: a lagging timeline and a bungled public rollout rife with controversies over its safety and efficacy.
Three experts Insider spoke with recently - Michaud, Bottazzi, and Fred Hutchinson's Dr. Larry Corey -agreed the vaccine is likely to win an emergency use authorization (EUA) from the US Food and Drug Administration. Andrew Berens, an industry analyst at SVB Leerink covering AstraZeneca, also recently told investors that the shot is likely to win US authorization.
The vaccine meets standards that FDA set last summer for experimental COVID-19 vaccines. In late-March, AstraZeneca announced success in a US-funded study, saying the vaccine was 76% effective at preventing symptomatic cases of COVID-19, and 100% effective at stopping hospitalizations and deaths. The study also found the shot was safe.
"From the data that we can see, it's a very good vaccine and doesn't raise any real red flags," Michaud said. "It would seem to be on a path to authorization."
If this was the first vaccine to produce late-stage results, that would have been seen as a phenomenal result. But vaccines from Moderna and from Pfizer demonstrated efficacy level of about 95%.
J&J's vaccine was less effective at preventing symptomatic illness. But that shot, too, has a unique case for being used. It's a one-dose vaccine with much milder side effects than Moderna's and Pfizer's. AstraZeneca's shot is given as two doses several weeks apart, as are vaccines from Moderna and Pfizer.
Also J&J's trial tested the shot in South Africa and Latin America at times when concerning virus variants had taken over, and showed the vaccine is still effective against these different strains.
In contrast, South African health regulators stopped distributing AstraZeneca's vaccine after a study found the vaccine was 22% effective at preventing mild-to-moderate COVID-19 in the country, and just 10% effective when looking only at cases caused by the B.1.351 variant.
Beyond that, AstraZeneca's vaccine has also suffered from a confusing and chaotic rollout. Some of the mistakes have been self-inflicted by AstraZeneca and Oxford, while others were out of its control. The latest controversy is over concerns that the vaccine could cause blood clots, particularly in younger women. While European regulators have said they have not found evidence of any link, some countries temporarily suspended the shot's rollout or limited its use in younger people.
Even with rollout in doubt, US authorization alone would hold value
A company spokesperson said that AstraZeneca plans to file with the US FDA for an emergency use authorization in the first half of April.
While FDA reviews of new medicines typically take at least half a year, the currently authorized COVID-19 vaccines have been reviewed in record time. Still, those evaluations require at least several weeks - meaning an EUA likely will come in May, at the earliest.
While experts aren't convinced the shot has a significant role to play in the US rollout, an FDA OK would still be helpful by boosting public confidence in the shot around the world, Bottazzi said.
Donating doses would bring the most global impact
The vast majority of COVID-19 vaccine doses have gone to rich nations in the first months of the rollout, according to Bloomberg's global vaccination tracker. AstraZeneca's vaccine has been one of the few programs that holds promise in helping not just wealthy countries but low- to middle-income nations, because the company is selling it at cheaper prices and also has said it can produce up to 3 billion doses in 2021.
If the US doesn't roll out the AstraZeneca vaccine domestically, it could to donate its doses. That could come either by direct, country-to-country donations, or through Covax, the WHO's vaccine equity program. Already, the US has given 4 million doses to Canada and Mexico.
AstraZeneca's shot would be a "very good candidate to donate to Covax," Kaiser's Michaud said.
"It would seem like that would be a good use for it, given that we do meet the needs of Americans with other vaccines that we have available," he said.