News

White House blocks new FDA safety guidelines on COVID-19 vaccine approval

The new FDA guidelines were submitted for approval to the Office of Management and Budget on September 21, although they stalled with White House Chief of Staff, Mark Meadows.

The White House has blocked stricter Food and Drug Administration (FDA) guidelines for the emergency release of the coronavirus vaccine, that would have likely prevented its approval before next month’s presidential election.

The new FDA guidelines were submitted for approval to the Office of Management and Budget on September 21, although they stalled with White House Chief of Staff, Mark Meadows. President Trump and top officials have been worried the new guidelines would delay the release of a vaccine, as Trump is frequently raising the possibility that an immunization will be available very soon.

Based on the new guidance, clinical testing requirements would involve volunteers in the late-stage clinical trials to be monitored for around two months after the final dose of the vaccine is administered, before an official vaccine authorization is granted. The stricter regulations were intended to ensure the vaccine is safe with no severe side-effects and to provide further acceptance of the vaccines by the wider public.

However, Trump previously flagged he may not approve the guidelines, alleging that it ‘was a political move more than anything else.’  Although he repeatedly insisted that a vaccine could be authorized prior to Election Day, public health experts and vaccine developers have stated that the timeline is very unlikely, suggesting an expected approval by the end of year and distribution in 2021 at the earliest.

With the White House blocking these stricter guidelines which were designed to ensure safety of a vaccine which was fast tracked through a process which usually takes years and not months, this is being seen by many as a political play by the Trump administration to improve their standing with American voters.

With the FDA’s hands tied in ensuring safety of patients who will be administered with these upcoming vaccines the responsibility now falls onto the shoulders of the vaccine developers themselves. These developers can now either take advantage of the situation and get this vaccine on the market as soon as possible or they can air on the side of caution and ensure there are no long term adverse reactions or side-effects. There are potential advantages and disadvantages of both approaches for the developers and patients, but the first option comes with significantly increased risks for patients considering these vaccines will potentially be administered to billions of patients which is incomparable to the thousands in the clinical trial cohorts.

The question now is will these developers put profits before patients?

If you would like to learn how GPI pulse™ can meet those needs and transform your value-based market access strategy in Europe and beyond then please book in some time with our experts below.

Share this News:

White house