The AstraZeneca/Oxford coronavirus vaccine has been given emergency approval by regulatory agencies in the United Kingdom, the European Union, India, and, on Thursday, South Korea.
But it is unavailable to Americans, and some are arguing AstraZeneca should submit the paperwork for an emergency use authorization immediately in the United States and that the Food and Drug Administration should approve it.
“I have tremendous faith in the [Medicines and Healthcare products Regulatory Agency], which is the British version of the FDA,” said Professor Peter Pitts, the president of the conservative Center for Medicine in the Public Interest and a former associate commissioner for external relations at the FDA. “I would be confident to say that if the MHRA reached a conclusion that the vaccine was safe and effective, the FDA would reach a similar conclusion relative to an EUA.”
The MHRA gave its emergency approval for the AstraZeneca vaccine in late December. On Wednesday, the World Health Organization also recommended that adults receive the AstraZeneca vaccine. At present, AstraZeneca is waiting until the U.S. part of its phase 3 trial is completed before submitting an EUA to the FDA. But that may not happen until April.
Back in September, it looked like the AstraZeneca vaccine would be the first to be approved in the U.S. But then, the company temporarily suspended its phase 3 trial of the vaccine due to safety concerns after a British participant developed inflammation of his spinal cord. It was later determined that the vaccine was not at fault, but the FDA did not let AstraZeneca’s phase 3 trial in the U.S. resume until late October.
When AstraZeneca released the data on the British arm of its phase 3 trial in December, it contained a surprise. A small number of participants had received only a half-dose of the vaccine during the first injection. However, the vaccine was 90% effective among that group, but only 62% among those who received two full doses. Research released last week found that the vaccine may be 82% effective after the second dose. The Pfizer and Moderna vaccines are about 95% effective.
That is leading some to suggest that it might be better if the FDA may be reluctant to give an EUA to AstraZeneca.
“Let’s assume for a moment that it is approved — who’s going to want it?” said Dr. Charles Dinerstein, medical director at the American Council on Science and Health. “If I had the choice, am I going to take the one that everyone thinks is not working so well? And, God forbid, they roll it out to people without their knowledge.”
Pitts believes that the difference between a vaccine with 95% efficacy and one with 62% is not the difference between an A grade and a D in regulatory terms.
“The FDA set a standard, and AstraZeneca met it,” said Pitts. “That vaccine is an excellent choice for anybody who wants to get vaccinated, and that should be everybody.”
On Monday, South Africa halted use of the AstraZeneca vaccine after a study found that it was less effective against mild or moderate cases of COVID-19 stemming from the South African variant of the virus. Dinerstein thinks that is another reason the FDA may be hesitant to issue an EUA.
“If the South African variant becomes more widely seen in the population here, then the vaccine has no efficacy,” said Dinerstein. “So from that piece of science, I think there is going to be some reluctance on the FDA’s part to approve it.”
But the South African study has been heavily criticized for studying primarily younger people — the average age of the participants was 31 — and not examining the vaccine’s effect on severe cases of COVID-19.
“Most trials look at whether you get sick and go to the hospital and die. That’s how the Moderna and Pfizer trials were reported out,” said George Rutherford, a professor of epidemiology and biostatistics and director of the Prevention and Public Health Group at the University of California, San Francisco. “The South African study only looked at if a person got infected. I suspect the AstraZeneca vaccine is just as effective as the other vaccines outside of that weird, narrow setting.”
