Today, the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK granted temporary authorization for emergency use of Pfizer and BioNTech's COVID-19 vaccine. The BNT162b2 vaccine is now the first in the Western world to receive authorization to battle the novel coronavirus.
Pfizer and German partner BioNTech said they will deliver the first doses—approximately 800,000—to the UK next week. In July, the pharmaceutical companies announced an agreement with the UK to supply 30 million doses of the mRNA-based vaccine once approved. That number was increased to 40 million in early October. To ensure “equitable allocation of vaccines,” Pfizer said delivery will continue in stages throughout 2021.
The BNT162b2 is a two-dose vaccine, so the initial 800,000 supply will be enough to vaccinate 400,000 individuals. Elderly persons in long-term care facilities and their caregivers will be the first to receive the vaccine, immediately followed by frontline health care workers and individuals 80 years and older. From there, the UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended an age-based program, with the inclusion of clinically extremely vulnerable individuals early on.
“The order of priority for each group in the population corresponds with data on the number of individuals who would need to be vaccinated to prevent one death,” JCVI explained in its recommendation. “The first priorities for the COVID-19 vaccination program should be the prevention of mortality and the maintenance of the health and social care systems.”
UK’s Secretary of State for Health and Social Care, Matt Hancock, confirmed the vaccine will be free at the point of delivery, according to clinical need, not ability to pay. He called it the “finest tradition of the National Health Service.”
According to Hancock, vaccination will begin in hospital hubs. This makes sense given the need for Pfizer’s vaccine to be stored at -70˚C, a temperature which large-scale hospital systems can support through ultra-low temperature freezers.
As more vaccines become available, possibly including versions from Moderna and AstraZeneca, Hancock said local doctor’s offices, pharmacies and vaccination centers in conference centers and sports venues will become part of the rollout plan. These venues, however, will more than likely house vaccines beside Pfizer’s version, as they do not have the instrumentation necessary to store pharmaceuticals below -20˚C.
“This will be one of the biggest civilian logistical efforts that we have faced as a nation,” Hancock said. “It will be difficult. There will be challenges and complications.”
With today’s approval, the UK becomes the first country in the West to approve a vaccine for COVID-19. (Russia and China have approved versions without a Phase 3 clinical trial). The UK’s greenlight was delivered quicker than most since the country used it’s “rolling review” regulatory process. Starting in October and continuing on a staggered basis as packages of data were released, a team of MHRA scientists and clinicians carried out a rigorous review. Essentially, most data were reviewed prior to Pfizer filing for emergency use, meaning only the final trial data needed to be assessed before approval.
In the U.S., the FDA has scheduled a meeting for December 10 to discuss the emergency use authorization (EUA) of BNT162b2, for which Pfizer and BioNTech submitted final trial data on November 20. The FDA has also scheduled a meeting on December 17 to discuss Moderna’s mRNA-1273 vaccine. The biotechnology company petitioned for an EUA on November 30.
Photo: Researchers at the University of Maryland School of Medicine supported clinical trials for Pfizer's COVID-19 vaccine. Credit: University of Maryland