Recent authorization of AstraZeneca’s COVID-19 vaccine in the United Kingdom and the European Union has raised the question: why not here?
Positive data from the vaccine released on Wednesday, combined with the urgent need for more doses in the US, is now fueling the debate.
Clinical trials in the United Kingdom, South Africa, and Brazil found that the vaccine was 76 percent effective after a single dose, rising to 82 percent when a second dose was given three months later.
However, the Food and Drug Administration (FDA) is awaiting the completion of a US clinical trial before it is expected to make a decision.
AstraZeneca has not yet applied to the FDA for authorization, and a top official said on Wednesday he does not think he can get it until the trial is over “the next month or two”.
“In terms of approval, we think we will need the US data,” Mene Pangalos, executive vice president of AstraZeneca, said at a news conference.
However, some experts say that it should at least be discussed whether the FDA and AstraZeneca should set aside the need for a domestic trial and instead use the foreign data that has already led to the authorization of key US allies such as the UK and the EU. has.
Others argue that it makes sense to wait for more data, as there have been questions about the AstraZeneca data, such as whether it works in people over 65 and what the correct dose is. A dosing error in the trial has led to some confusion on these fronts.
Ashish Jha, dean of the Brown University School of Public Health, said it was a “reasonable decision under normal circumstances” for the FDA to wait 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 transmissible variant, first identified in the UK, is a threat to the US and could lead to a major increase in business in the coming weeks. Public health experts widely agree that there is now an urgent need to vaccinate as many people as possible quickly to try to numb the spike.
But there are not enough doses for everyone in the United States with just the Pfizer and Moderna vaccines, so the addition of doses of AstraZeneca can give a big boost. Johnson & Johnson applied for authorization on Thursday night, so it could also be added to the arsenal soon.
“This is a debate we need to have,” Jha said, noting that UK and EU regulators who have already approved the vaccine “clearly have a high degree of scientific integrity.”
However, some experts say that there are many unanswered questions about the AstraZeneca trials that need to be resolved first.
AstraZeneca’s “analyzes are largely exploratory about a mix of different trials, doses and timing of vaccines. We need clear prospective data from the current US trial to resolve this, ”Eric Topol, a professor of molecular medicine at Scripps Research, wrote in an email.
“I do not think there should be pressure on the FDA to approve the vaccine before then,” Topol said.
The FDA declined to comment on the details of the process surrounding AstraZeneca’s vaccines, citing regulations regarding the discussion of individual companies seeking authorization, and referring questions to AstraZeneca.
“Phase III UK trial data has been shared with the FDA,” said AstraZeneca spokesman Brendan McEvoy. “Once the data from the US Phase III trial is available, it will also be submitted to the FDA.”
Norman Baylor, a former director of the FDA’s vaccine office and now a pharmaceutical consultant, pointed to possible problems with the company’s data.
‘We know that, due to the lack of a better word, there were a few bumps in the road, so to speak, with AstraZeneca, and I think the FDA is probably trying to deal with that and really clear image of it, ”he said.
Regulators in Germany and France, for example, have said there are insufficient data to authorize the vaccine for people over 65, and have therefore only granted it to people under the age of 65.
Baylor said that if the FDA thinks the data from the foreign trial is sufficient, it can tell AstraZeneca: ” Yes, we think the data is sufficient now. Why are you not going to submit the data, then we will start reviewing it? ‘”
“But it’s clear that it’s not entirely adequate for the FDA, or yes, they would have done it,” he said. “They do want to see the details of the American trial.”
It is also unclear how many doses of the AstraZeneca vaccine would be available immediately in the US if allowed. The federal government has agreed to buy as many as 300 million doses, but the company has not said how many will be available in the short term.
Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Safety, said there were compromises, and that the FDA had “more transparency” in its decision-making and “probably wants to handle the data better” than what is available at AstraZeneca so far .
Still, he said: “we all want to see everything go at a faster pace,” and “there is something to be said for the UK 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 outspoken about the authorization of the vaccine.
“There’s no excuse that AZ’s vaccine already approved abroad and used there is very promising, can be produced quickly, and where only a single dose is very effective, is not now available to Americans, said Brian Blase. , who is a health adviser to former President Trump
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After Trump publicly attacked the FDA on Twitter during his presidency, leading to widespread condemnation by scientists over undermining the review process, President Biden stressed that he would not put any political pressure on the FDA.
Ultimately, Brown’s Jha said, the decision to wait for more US trial data on AstraZeneca is likely to be judged on how severe the increase in coronavirus variants ultimately is.
“I do think the pressure on them will increase if things look bad,” he said.