May 8, 2021

DCTRS

Damascus Center for Theoretical and Civil Rights Studies

Editorial: All drugs come with risk. The COVID vaccines are no different

All medicines, including those sold over the counter, come with a risk to the user. And as those otherwise breezy commercials for pharmaceuticals remind us, the most serious risk may include death. COVID-19 vaccines are no exception.

That’s why federal regulators responsibly recommended a pause in the use of Johnson & Johnson’s COVID-19 vaccine and started to investigate a half-dozen cases of a rare and dangerous blood-clotting disorder, cerebral venous sinus thrombosis, in younger women who’d recently been immunized. One of those cases was fatal. The cases are strikingly similar to those recorded in Europe among mostly younger women who received the AstraZeneca COVID-19 vaccine, which relies on similar technology to generate antibodies.

This is how the regulatory process for new drugs is supposed to work when a serious side effect emerges. The pause gives officials time to educate healthcare providers on how to detect and treat the disorder, while also alerting the public to potential dangers, examining whether the cases are caused by the vaccine and weighing the overall risks and benefits of continuing to use the vaccine.

Now federal regulators are grappling with the way forward that balances the relatively low risk posed by the Johnson & Johnson vaccine (seven cases of blood clots out of 7.2 million shots administered in the U.S., 1.5 million of them to women between the ages of 18 and 48) against the danger of slowing the U.S. mass immunization effort as infections surge again in some parts of the country.

The pause should not drag on indefinitely, but that’s what may be happening. On Wednesday, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices adjourned without deciding whether to recommend continued use of the Johnson & Johnson vaccine in the U.S. Instead, the committee will wait until some undetermined time in the future to reconvene and possibly decide then.

It’s understandable that these vaccine experts would want more data, considering that about half of the doses of the Johnson & Johnson vaccine have been administered in the last two weeks and there may be more potential cases of the clotting disorder. If there’s a spate of them in the next few days — which seems unlikely, given the rarity so far and the low incidence of the disorder among those who received the AstraZeneca vaccine — then the committee members’ caution will be justified.

But inaction has consequences. In this case, it means the 9.2 million doses of the one-shot vaccine that have been delivered to immunization sites will sit unused on shelves instead of protecting 9.2 million people from COVID-19. President Biden assured the public Tuesday that there would be enough doses of the vaccines produced by Pfizer and Moderna to inoculate all adults in the U.S. who want to be vaccinated by the end of May. But every day for the last week, there were more than 70,000 new COVID-19 cases documented in the U.S., and about 5,000 additional deaths from the disease.

Committee member Dr. Camille Kotton, an infectious disease specialist at Massachusetts General Hospital, put the pause in human costs: “We were going to use this vaccine for homebound, high-risk, underserved populations, hard-to-reach [people]. We need to be cautious and careful, but losing this one-and-done vaccine that didn’t require cold [storage] is a significant loss.” Unlike the Johnson & Johnson vaccine, the Moderna and Pfizer offerings require two injections to achieve maximum protection.

A prolonged pause may also exacerbate vaccine hesitancy. While federal health officials say that their fast action on this vaccine should instill confidence in the public that regulators are closely monitoring the safety of the COVID vaccines (and they are), we worry about the people who don’t read past the scary headlines.

Indeed, it seems that the rare blood clotting disorder is taking a toll on immunization efforts in Europe by lowering confidence even as infections there are climbing. And on Wednesday, Denmark announced it was dumping the AstraZeneca vaccine. That seems like an extreme overreaction. It’s important that authorities carefully weigh the risks for any medication against the benefits, but no matter how you look at the data, the bad outcomes for Johnson & Johnson and AstraZeneca are few and far between.

We need more data to lower the risk even more, but ultimately, we may have to accept that there is a serious, if rare, side effect with some vaccines, then do what we can to limit their use to people at lower risk for clots but higher risk of COVID-19 infections. At the moment, that appears to be people over age 50 and adult men of all ages.

Speaking of pauses, let’s do that here for a moment to put this particular debate in the larger context: As of Wednesday, 75 million people in the U.S. have been vaccinated against COVID-19 with virtually no major adverse effects. That’s a success by any measure. Regardless of the questions about the Johnson & Johnson vaccine, the public should feel supremely confident that the COVID vaccines are safe and effective.