American regulators will scrutinize every bit of trial data from AstraZeneca before approving its COVID-19 vaccine, the White House said Wednesday, hoping to stem the fallout from a series of public relations blunders around a promising vaccine that would bolster U.S. supply and give poor nations a much-needed weapon against the virus.
The drugmaker said in a press release Monday that its vaccine was 79% effective against all forms of the disease. Federal data monitors swiftly scolded the company, saying the pharmaceutical giant didn’t include more recent data that would slightly lower the efficacy rate. AstraZeneca said it will provide updated results this week that are “consistent with” the data it announced Monday.
U.S. officials characterized the controversy Wednesday as a bump in the road as they try to keep the vaccine effort rolling at full steam. They said the Food and Drug Administration will take a rigorous look at all the data before deciding whether to authorize the vaccine for emergency use in the U.S.
“We never look at the numbers in a press release to make that determination. That’s always a much more in-depth submission,” presidential adviser Andy Slavitt said Wednesday during a COVID-19 briefing. “So I would urge us not to focus on the process of the last couple of days, but instead to focus on what really matters, which is what happens when these applications for these candidates are submitted to the FDA.”
Still, the dust-up comes several months after a trial-dosing blunder and days after European regulators tried to reassure nations that paused their AstraZeneca rollouts because of blood clotting in some recipients.
“I do think the unfortunate series of events surrounding this vaccine will pose a difficult public communication problem. There is already vaccine hesitancy, and many people are not going to remember the intricate details about this vaccine and its safety and efficacy, but they will remember the negative headlines,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
Some reports say the efficacy rate demonstrated in the U.S. trial may be closer to 69% to 74% than to 79%. That is still good and could help wrangle the pandemic, but the discrepancy must be worked out.
“The data and safety monitoring board was quite concerned that the data that was reflected in the press release was not the most recent, updated data that was more accurately reflective of what the vaccine efficacy point was,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in the briefing.
“At the end of the day, you know, when you look at the data, this is going to turn out to be a good vaccine,” he said.
The company found no evidence of blood clots in U.S. trial participants and said the shots completely staved off severe disease and hospitalization.
“We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus,” Executive Vice President Mene Pangalos said Monday. “We are preparing to submit these findings to the U.S. Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted U.S. emergency use authorization.”
It is not clear whether the U.S. will need the AstraZeneca version, which could be approved by May. Nearly 1 in 3 U.S. adults — a quarter of the overall population — have received at least one dose of vaccines from Pfizer-BioNTech, Moderna or Johnson & Johnson. More than 1 in 6 adults are fully vaccinated.
“Put another way, no country has vaccinated more people than the U.S.,” Mr. Slavitt said.
President Biden expects to have enough doses of the existing trio of vaccines for every U.S. adult by the end of May, and he recently loaned 4 million doses of the AstraZeneca vaccine to Canada and Mexico.
Adding the vaccine to the national arsenal, however, could give the U.S. some supply for teens and children or give Americans options if variants prolong the virus fight.
Developed with Oxford University, the AstraZeneca vaccine is relatively inexpensive and is earmarked as the main vaccine for developing countries.
It was a front-runner in the vaccine race last year but faced U.S. hurdles, including delays in sorting through data about an adverse event in a British recipient. Also, some trial participants were given a half dose before a full dose of the two-shot vaccine by mistake.
Shipping delays caused friction between the drugmaker and the European Union. The latest point of contention was the discovery of nearly 30 million doses at a facility in Italy, though the company said Wednesday that 13 million of the doses are designated for COVAX, a global vaccine-sharing program, and another 16 million will be dispatched to Europe, so it is “incorrect to describe this as a stockpile.”
“The PR around this vaccine has been a problem since the beginning in terms of missed opportunities by their CEOs and later the individual European countries sending out warnings only to have the [European Medicines Agency] walk it back. And now this,” said Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine, referring to the U.S. data spat. “I hope they can make things right since this is one of our workhorse vaccines we need for low- and middle-income countries.”
The vaccine is relatively easy to store, and the U.K. is making good use of it under a strategy that delays the second dose so a wider swath of people can get some level of first-dose protection sooner.
In the U.S., meanwhile, officials said the vaccines in circulation appear to be working well.
Dr. Fauci cited an analysis that found 234 infections among 8,000 unvaccinated health care workers at a Dallas medical center and 112 infections in 6,000 workers who were partially vaccinated with one dose. Among those fully vaccinated, only four out of more than 8,100 employees had infections.
The “0.05% infection rate among fully vaccinated employees — a real proof-positive of the importance of vaccination,” Dr. Fauci said.
Biden administration officials tempered their enthusiasm with concerns about case counts leveling off while the vaccination campaign continues.
“We’re still hanging out at 55,000 cases a day, and we’re watching what’s happening people in people who are vacationing right now, and that concerns me a lot,” said Rochelle Walensky, director of the Centers for Disease Control and Prevention.
She cited footage of spring break revelers who were flouting COVID-19 precautions.
Dr. Fauci said the U.S. is “at the corner,” not around it, in fighting the pandemic.
“Whether or not we’re going to be turning the corner still remains to be seen,” Dr. Fauci said. “We do have a lot of challenges in front of us with regard to the high level of daily infections.
“When you’re at that level, I don’t think you can declare victory and say you’ve turned the corner,” he said. “You’ve got to continue to do what we’re doing: more vaccinations, and continue to do public health measures until we actually do turn the corner.”
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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