By Beatriz Pascual Macias
Washington, Dec 11 (efe-epa).- The US government is poised to approve the Covid-19 vaccine developed by pharmaceutical giant Pfizer Inc. in collaboration with BioNTech and the drug is likely to reach patients early next week, the secretary of health and human services said Friday.
“We could see people getting vaccinated Monday, Tuesday of next week,” Alex Azar said on ABC television’s “Good Morning America.”
The Food and Drug Administration (FDA) said early Friday that it notified Pfizer of its intention to “rapidly work toward finalization and issuance of an emergency use authorization for the BNT162b2 vaccine.
The FDA said that it also alerted the Centers for Disease Control and Prevention (CDC) and Operation Warp Speed, the Trump administration’s initiative to expedite development of a vaccine for Covid-19.
The United States leads the world in coronavirus deaths with nearly 293,000, and in confirmed cases, which have topped 15.6 million.
On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 17-4 with one abstention in favor of recommending that the authorization be granted.
Though the Pfizer drug must still secure approval from the CDC before distribution can begin, outgoing President Donald Trump took to Twitter on Friday to demand that the FDA director, Dr. Stephen Hahn, “stop playing games and start saving lives!!!”
The Washington Post reported that Trump’s chief of staff, Mark Meadows, called Hahn early Friday to say that he should start looking for a new job if the FDA didn’t issue the authorization by the end of the day.
“This is an untrue representation of the phone call with the Chief of Staff,” Hahn said Friday afternoon. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s (emergency use authorization) request.”
Federal authorities say they are ready to ship 2.9 million doses of the Pfizer vaccine within days of regulatory approval, while holding an equal number in reserve to provide the required second dose three weeks later.
The CDC has said that in deciding who should be the first to get the vaccine, priority should be given to front-line health-care workers and residents and staff at nursing homes.
Pfizer, which is based in the US, and Germany’s BioNTech said that data from Phase 3 clinical trials involving nearly 44,000 people worldwide showed BNT162b2 to be 95 percent effective at preventing infection with the coronavirus.
Observers have expressed concern about the complex handling requirements for the Pfizer/BioNTech drug, which must be maintained at a temperature of minus 70C (minus 94F).
But Pfizer, the world’s second-biggest pharmaceutical firm, said it was “confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.”
Pfizer and BioNTech said they have the capacity “to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.”
Another US firm, Moderna, is seeking emergency use authorization for its Covid-19 vaccine and several other vaccine candidates are undergoing Phase 3 clinical trials, including one developed by British-based AstraZeneca in collaboration with the University of Oxford; CoronaVac, a creation of China-based Sinovac Biotech; and Russia’s Sputnik V.
While those candidates have emerged with unprecedented speed, a safe, effective vaccination cannot come soon enough for the US, where the number of infections is climbing by more than 200,000 a day on average.
Wednesday was the worst day of the pandemic in the US so far, with 3,055 fatalities.
“We are in the time frame now that probably for the next 60 to 90 days we’re going to have more deaths per day than we had at 9/11 or we had at Pearl Harbor,” CDC Director Dr. Robert Redfield said Thursday during an event hosted by the Council on Foreign Relations.