Drug Companies Pledge to Uphold Vaccine Safety, but is it Enough?

CEOs of nine of the largest pharmaceutical manufacturers in the world recently signed a pledge to maintain the safety of the eventual COVID-19 vaccine. All of these companies, including AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, are currently working toward bringing an effective coronavirus vaccine to market. They are all in various stages of clinical trials.

Many believe the pledge was designed to assuage concerns that the government’s eventual approval of the drug may be politically motivated. We live in a divided nation, and some people remain skeptical of President Trump’s ability to adhere to the latest recommendations from the scientific community.

A Political Vaccine?

During a recent rally, the president said, “So we’re going to have a vaccine very soon, maybe even before a very special date. You know what date I’m talking about.”

It’s likely that the president was referring to Nov. 3rd, the day of the election. Any breakthrough with a vaccine could help increase his chances of victory. According to a recent survey, around a third of Americans say they wouldn’t get an FDA-approved COVID-19 vaccine, even for free.

Many argue that the president doesn’t have a great track record when it comes to advising the general public on the virus. He has repeatedly encouraged the use of hydroxychloroquine as a possible treatment for COVID-19. The FDA authorized the drug for emergency use in March, but recent health concerns led the agency to suspend its usage.

The president has also suggested that injecting bleach may stop the spread of the virus (whether he was “joking” or not), so it’s clear why so many people are skeptical of a possible “Trump Vaccine.”

A Pledge to Safety

This pledge aims to show people that these companies have the public’s best interest at heart. The companies said they wouldn’t submit their findings to the FDA for approval until they can prove that the eventual vaccine is safe and effective, limiting the president’s ability to approve an untested vaccine.

Industry experts say the pledge is historic. These companies are competitors in nature, all working towards the same goal. As Ameet Sarpatwari, the assistant director of the Program on Regulation, Therapeutics and Law at Harvard Medical School, told NPR, “I think it reflects an acknowledgment of the widespread concern that FDA decisions are currently being guided by politics and not science.”

However, he also argues the pledge doesn’t go far enough. For example, it doesn’t say that the companies will share all their data with the FDA once they’ve proven that the drug is effective. This means pharmaceutical manufacturers could share partial data with the government, possibly overlooking some of the vaccines’ more harmful side-effects.

The pledge also doesn’t say whether these companies will release their findings to the general public on a timely basis. This could sow doubt and confusion across the country when vaccines finally reach the market.

The FDA Fires Back

The number of people who say they’re willing to take a COVID-19 vaccine is alarming to health experts, and spreading fear and misinformation about it could lead to a range of unintended consequences. The FDA has made it clear that it will not play politics with an eventual vaccine.

After the president’s remarks, Stephen Hahn, the FDA commissioner, said he would resign if asked to release a vaccine too early. He also admitted that it’s possible the scientific community will have a working vaccine by Election Day, but that politics will have nothing to do with it.

Hahn was also quick to acknowledge the pressure his agency is feeling from all sides, including politicians and business leaders. “There’s been pressure throughout this pandemic, and I think anybody who doesn’t acknowledge that would be kidding themselves. There’s been pressure to make sure that we get medical products as quickly as possible to the American people.”

The CEO of Pfizer also said there’s about a 60% chance the company will know whether its vaccine is safe and effective by Election Day. But that doesn’t mean the public will receive the vaccine by then.

It’s clear that many people are uneasy about the idea of taking a COVID-19 vaccine. Regardless of how they feel about politics, remind your patients that experts in the science and medical community are doing everything they can to ensure that it will be as safe as possible before releasing it to the public.