Recent authorization of AstraZeneca’s COVID-19 vaccine in the UK and the European Union has raised the question: why not here too?
Positive data from the vaccine released Wednesday, combined with the urgent need for more doses in the US, is now fueling the debate.
Clinical studies in the UK, South Africa and Brazil have shown that the vaccine is 76 percent effective after a single dose, increasing to 82 percent when a second dose is given three months later.
However, the Food and Drug Administration (FDA) is waiting for the completion of a US clinical trial before it is expected to make a decision.
AstraZeneca has not yet filed for authorization from the FDA, and a top company official said on Wednesday that it does not think it can get it until the lawsuit is over in “the next two months.”
“In order to get approval, we think we need that US data,” Mene Pangalos, executive vice president at AstraZeneca, said at a news conference.
However, some experts say there should at least be a discussion about whether the FDA and AstraZeneca should put aside the need for a domestic trial and instead use the foreign data that has already led to authorizations by key US allies such as the UK and the EU.
Others feel it makes sense to wait for more data as there are some questions about the AstraZeneca data, such as whether it works in people over 65 and what is the right dose. A dosing error in the trial has led to some confusion on those fronts.
Ashish Jha, dean of the Brown University School of Public Health, said it is “a reasonable decision under normal circumstances” if the FDA waits for “cleaner” data from the US trial.
But, he added, “there is a reasonable question to ask: are these normal circumstances?”
He noted that a more transmittable variant first identified in the UK lurk as a threat to the US, and could lead to a “massive spike in cases” in the coming weeks. Public health experts generally agree that there is now an urgent need to vaccinate as many people as possible quickly to reduce that spike.
But there aren’t nearly enough doses for everyone in the US with just the Pfizer and Moderna vaccines, so adding doses of AstraZeneca could be a big boost. Johnson & Johnson applied for permission on Thursday evening, so it could be added to the arsenal soon.
“That’s a debate we should have,” said Jha, noting that regulators in the UK and EU who have already approved the vaccine “clearly have a high degree of scientific integrity.”
However, some experts say there are many unanswered questions about the AstraZeneca studies that need to be resolved first.
AstraZeneca’s “analyzes are largely exploratory on a mix of different studies, doses and timing of vaccines. We need clear prospective data from the ongoing US trial to resolve this, ”Eric Topol, professor of molecular medicine at Scripps Research, wrote in an email.
“I don’t think there should be any pressure” on the FDA to approve the vaccine before then, Topol said.
The FDA declined to comment on the specifics of the trial surrounding AstraZeneca’s vaccines, citing regulations about discussing individual companies seeking consent, and referred inquiries to AstraZeneca.
“Data from the Phase III study in the UK has been shared with the FDA,” said AstraZeneca spokesperson Brendan McEvoy. “As soon as data from the US Phase III study is available, it will also be submitted to the FDA.”
Norman Baylor, a former director of the FDA’s vaccine agency and now a pharmaceutical advisor, pointed out potential issues with the company data.
“We know, for lack of a better word, there have been some bumps in the road, so to speak, with AstraZeneca, and I think the FDA is probably making an effort with that and really getting a clear picture of that, ‘he said.
For example, regulators in Germany and France have said that there is not enough data to approve the vaccine for people over 65, and have therefore only allowed it for people under that age limit.
Baylor said if the FDA thought the data from the foreign trial was sufficient, it could tell AstraZeneca, “’Yes, we think the data is sufficient now. Why don’t you go ahead and submit the data for us to review? ”
“But it’s clear that that’s not quite enough for the FDA or, yes, they would,” he said. “They want to see the data from the US trial.”
It’s also unclear how many doses of the AstraZeneca vaccine would be immediately available in the US if it were approved. The federal government has agreed to purchase as many as 300 million doses, but the company has not said how many would be available in the short term.
Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said there are tradeoffs, and that the FDA has “more transparency” in its decision-making and “would probably want to do better with the data” than what has been available so far at AstraZeneca.
Still, he said, “We would all like to see things move at a faster pace” and “there is something to be said about the UK’s approach.”
Like many aspects of the coronavirus pandemic, there is also a political element surrounding the AstraZeneca vaccine debate.
Some on the right are particularly vocal about approving the vaccine now.
“There is no excuse that the AZ vaccine already approved and used abroad shows promise, can be produced quickly and where only a single dose is highly effective is now not available to Americans,” says Brian Blase . , who was a health advisor to the former President Trump
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After Trump publicly attacked the FDA on Twitter during his presidency, leading to widespread condemnation by scientists for undermining the review process, President Biden has insisted that he will not put political pressure on the FDA.
Ultimately, said Brown’s Jha, the decision to wait for more US trial data on AstraZeneca will likely be judged by how severe the coronavirus variants spike eventually becomes.
“I think the pressure on them will increase if it looks bad,” he said.