There is no shortage of scientists raising legitimate questions about Pfizer’s news release heralding the overwhelming positive results from its COVID-19 vaccine trial. database

Did the early results reflect a valid sampling of the populations most at risk of contracting the disease—the elderly, minorities and people with chronic medical conditions? Will the reported 90% reduction in disease incidence also reduce hospitalizations and deaths? Will the vaccine confer long-term immunity?

Allow me to add my own observation. Based on the limited data released by Pfizer, disease incidence in the placebo arm appeared to be about 75% below the general population over the first 3½ months of the trial.

When I emailed those surprising numbers to Dr. Paul Offit of the University of Pennsylvania, one of the nation’s leading vaccine experts, he didn’t dispute them. “It might be that people who choose to be in these trials are more careful about their health, more likely to wear masks and social distance than the general population,” he wrote back.

If that holds true, it would confirm what public health officials have been telling us since March: Universal masking, social distancing and targeted shutdowns in areas with severe outbreaks are enough to bring the pandemic under control. And it can be accomplished long before a vaccine has been rolled out and administered to a substantial share of the population, which is at least six months away.

Science by news release—when there’s no published data, no peer review and no outside oversight beyond the company’s own external data-monitoring committee—is never a good idea. Pfizer’s premature announcement, even though it does look promising, is like heralding an election outcome based on day-of voting and not waiting for the mail-in votes to be counted.

Pandemic control efforts would have been far better served had Pfizer quietly reported its preliminary data to the Food and Drug Administration and allowed the regulatory process to proceed as planned. The FDA has promised full transparency and a public advisory committee review before authorizing emergency use of the vaccine.

There’s another reason why it is unwise to allow corporate hype to overshadow outside scientific review. One of the biggest tasks facing public health officials in the months ahead will be convincing skeptical Americans to get the shot. Pfizer’s vaccine will require two of them a month apart.

Americans need to know not only that it’s effective, but that it’s safe. Pfizer said its data committee observed no “serious safety concerns.” But if my experience with this year’s flu shot is any indication, there will be some share of the vaccinated population that will experience short-term reactions beyond the usual arm soreness or redness at the injection site.

After my shot (I got the heightened senior dose), I spent about 12 hours with a low fever and severe shaking, which began about 12 hours after the injection. Effects like these need to be fully categorized and publicized so people know what to expect.

The nation also needs a much better post-approval monitoring system. Right now, the FDA’s Vaccine Adverse Event Reporting System relies on voluntary reports. A decade ago, an Agency for Healthcare Research and Quality-funded study, which used electronic health records from Atrius Health in Massachusetts, found fewer than 1% of vaccine-related adverse events were reported to the FDA.

That study’s methodology points the way to a better system. The government needs to create a national database that pulls in both claims and medical records that public health officials can monitor in close to real time for rare but serious adverse events from vaccines and drugs.

Such a database would go a long way toward reassuring the public that the new COVID vaccine is safe and effective—not just in limited clinical trials, but as it being used in the general population.


Source: U.S. needs database closely tracking all vaccine adverse events