U.K. approves Pfizer’s COVID vaccine
Tested in Groton, all eyes are now on FDA
With a vote of confidence in safety studies led by scientists in Groton, United Kingdom regulators approved a COVID-19 vaccine for emergency use developed by Pfizer and BioNTech, as the Food & Drug Administration proceeds with its own studies required for U.S. distribution.
The FDA has scheduled a daylong open session on Dec. 10 to consider the Pfizer-BioNTech application for emergency use authorization. Early trials have demonstrated a 95 percent efficacy rate, with U.K. regulators citing the vaccine as “generally well tolerated” by clinical trial volunteers, including seniors. Pfizer and BioNTech reported previously that only a small percentage of trial participants experienced side effects including fatigue and headaches.
Pfizer has its main safety and efficacy research lab in Groton, with the New York City-based giant having its lead vaccine research facility in Pearl River, N.Y. BioNTech is based in Germany, with its founders having been developing vaccines to ward off cancer before redirecting their efforts to the search for a coronavirus vaccine. The vaccine is designed to give the body genelevel instructions on how to create harmless versions of the virus causing COVID-19, improving its defenses if exposed to the real virus.
The Medicines and Healthcare Products Regulatory Agency issued its approval Wednesday morning, with Pfizer having been stocking inventories globally in expectation of approval. The vaccine must be stored at temperatures approaching 100 degrees Fahrenheit below zero, making it likely that the Pfizer vaccine will be used at the outset to inoculate doctors and nurses at hospitals that have “ultra-low” freezers that can maintain those temperatures. Pfizer has designed containers that can store the vials in dry ice at the temperatures need to preserve the vaccine.
A spokesperson for Yale New Haven Health indicated in midNovember that the system had freezer capacity sufficient to store 100,000 doses, and that it was seeking additional equipment. Yale New Haven Health facilities include Bridgeport Hospital, Greenwich Hospital and Lawrence + Memorial Hospital in New London.
“This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” Pfizer quoted CEO Albert Bourla saying, in a Wednesday press release. “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a highquality vaccine around the world.
With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”
A COVID-19 Vaccine Advisory Group is crafting recommendations for Gov. Ned Lamont on the scientific analysis of vaccines — the group met Monday night — as well as how to prioritize who will receive the limited supplies of early vaccines and how Connecticut residents will be kept informed of opportunities to get vaccinated. Allocation and communications subcommittees meet Thursday to review progress on those fronts.
On Tuesday, Lamont’s office reported 20 more deaths of Connecticut residents from complications of COVID-19, with the virus now having killed 5,040 people of more than 118,750 people thought to have come down with coronavirus. CDC reported this week that Connecticut has the third highest coronavirus death rate in the nation after New Jersey and Massachusetts. Physicians diagnosed 1,459 fresh cases in Connecticut as detailed in the Tuesday report from Lamont’s office.
On Monday, Lamont said he expects Connecticut to receive 20,000 doses of the Pfizer vaccine by Dec. 14, which administered in two doses would be sufficient for 10,000 people. Under oversight of the Centers for Disease Control & Prevention, Pfizer is shipping doses directly to hospitals, with the company having a major manufacturing plant in Andover, Mass.
Distributor McKesson is taking the lead for vaccines from other drug companies that do not require ultra-low freezer storage, which will go to health clinics operated by CVS, Stop & Shop, Walgreens and other pharmacy and retail chains.
Cambridge, Mass,-based Moderna has also filed a two-dose vaccine candidate for FDA approval, with Lamont saying he expects another 20,000 doses on that front this month. The FDA has scheduled a Dec. 17 meeting to discuss Moderna’s application for emergency-use authorization.
AstraZeneca is also developing a vaccine in partnership with the University of Oxford, as is Johnson & Johnson alongside Janssen Pharmaceuticals.