Amid intense pressure on U.S. regulators to approve a Covid-19 vaccine at “warp speed,” including from an impatient President Donald Trump himself, the U.K. has pulled off a major coup and become the first country in the world to authorize a vaccine for emergency use based on clinical data, raising questions as to when the Food and Drug Administration will approve the vaccine for a disease that has killed over 270,000 people nationwide.
Vaccine makers will likely provide all regulatory bodies around the world with the same information and data from their clinical trials, but regulators have different approaches and procedures they must follow in order to approve a new medicine, even under emergency conditions.
As it stands with Covid-19 vaccines, the U.S. is simply acting at a slower pace than the U.K., which has been able to pull ahead for a number of practical and logistical reasons.
The MHRA, Britain’s medicines regulator, reviewed evidence from pharmaceutical companies on a rolling basis and was able to ask questions and consult specialists along the way, while Brexit has allowed it to take unilateral action as opposed to acting in accordance with EU timelines.
What’s more, the regulator has a reputation for being a “very efficient organization,” according to Dr. Penny Ward, a visiting professor at King’s College London.
In the U.S., however, the FDA has a few more logistical hurdles to clear, including completing an internal assessment of the data provided to it by Pfizer, and consulting an external advisory board prior to making any decision, all of which will take time to organize and complete.
Currently, the FDA advisory board is scheduled to meet on Dec. 10 (and on Dec. 17 for Moderna’s vaccine candidate), with a decision expected shortly after.
Britain’s vaccine coup will likely frustrate Donald Trump, who has been desperate to claim vaccine successes as personal victories, even if he and his administration’s Operation Warp Speed scheme to deliver a Covid-19 vaccine have had nothing to do with its development, as is the case with the Pfizer-BioNTech vaccine. This will be exacerbated by the fact that one of the two developers, Pfizer, is an American company (BioNTech is German). With Moderna and Pfizer releasing successful trial data, Trump has been piling the pressure onto the FDA to approve the vaccines for emergency use as soon as possible, reportedly going so far as to summon commissioner Stephen Hahn to the White House for questioning on Tuesday. Unperturbed, Hahn calmly and publicly explained that this must be done “the right way.”
In announcing the decision to approve the Pfizer-BioNTech vaccine, chief executive of the U.K.’s medical regulator, Dr. June Raine, stressed that “the public’s safety has always been at the forefront of our minds” adding that the organization is “globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine.”
What We Don’t Know
States are largely free to distribute vaccines as they wish, though there is central guidance from the Centers for Disease Control and Prevention recommending priority for medical workers and the staff of care facilities.