While Israel’s seen dynamite data from its third vaccine shots and England is set to follow suit, America could be held hostage to a brewing Beltway booster battle.
The Food and Drug Administration just refused to recommend approval of Pfizer’s application to give the general public third COVID-vaccine doses. Team Biden wants to start its booster campaign next week — but doesn’t seem willing to shake the FDA out of its return to business-as-usual hypercaution to do it.
The FDA released a report Wednesday — two days before an outside panel considers Pfizer’s request — concluding it didn’t have enough information to give the go-ahead. “Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” it said. “There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions.”
So the agency won’t even trust the three studies from the Centers for Disease Control and Prevention that President Joe Biden cited in calling for a booster campaign. One, from New York, found that vaccine efficacy against infection dropped from 92 to 80 in under three months. Another saw Pfizer’s efficacy go from 76 to 42 percent over a few months.
Pfizer’s clinical trial showed subjects given a third jab had significant increases in antibodies that neutralize the virus, putting them back up to the 90 to 95 percent protection following a second dose. The FDA admitted it judged this third dose a safe and effective vaccine. It’s already given the OK for boosters among the moderately to severely immunocompromised.
Even more data have come out of Israel, the first country to approve boosters for all. One study found a third dose produces 10 times more antibodies than a second.
Yet the FDA is skeptical of “observational studies” and claims those done abroad might not “most accurately represent vaccine effectiveness in the US population.” But as Marty Makary, Johns Hopkins University School of Medicine professor, points out in The Wall Street Journal, “American public health agencies should be producing data on breakthrough infections, boosters and natural immunity” but aren’t. Israeli studies are being published weeks after completion, “not months later as often happens in the US.”
Friday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee will be opened by Marion Gruber, director of the FDA’s Office of Vaccines Research and Review. She’s on her way out, along with her deputy, Phil Krause, reportedly because they’re unhappy the administration is pushing booster shots ahead of an FDA OK. They both argued in a recent Lancet piece that the public didn’t yet need booster shots — especially since many poor countries have dismal vaccination rates.
In other words, the science bureaucrats are playing politics.
Yes, even after months, the vaccines’ protection against serious illness and death doesn’t seem to wane. But those more at risk of severe illness should have the booster option. America has donated millions of doses to other countries — and vax production can ramp up; it’s not a zero-sum game.
Note, too, that the Moderna jab may be more effective than Pfizer’s — but the smaller company is still jumping through FDA hoops even to get final approval for its two-shot vaccine, which has already gone into millions of arms without a hitch.
President Donald Trump created Operation Warp Speed to cut through bureaucratic red tape and produce vaccines in record time. Biden might take a page from that if he truly believes in his booster campaign.