Americans to get Pfizer’s Covid-19 vaccine ‘in less than 24 hours’, Trump says
- The US has granted Pfizer emergency authorisation to roll out its vaccine amid soaring infections and deaths
- The inoculation is expected to be given first to health care workers and residents of long-term care facilities
Pfizer has gained emergency US authorisation for its Covid-19 vaccine, becoming the first shot that will be deployed to Americans amid soaring virus-related hospitalisations and deaths.
“I am authorising the emergency use of Pfizer-BioNTech Covid-19 vaccine for the prevention of Covid-19,” Denise Hinton, the Food and Drug Administration’s chief scientist wrote in a letter to a Pfizer executive on Friday.
Trump administration threatened to oust head of the FDA over Pfizer vaccine
“The first vaccine will be administered in less than 24 hours,” he said in a televised address released on Twitter. “Through our partnership with FedEx and UPS, we have already begun shipping the vaccine to every state and postcode in the country.”
Trump added that governors would decide who would receive the shots first in their states.
01:55
Coronavirus vaccine: UK grandmother is first person outside trials to get Pfizer Covid-19 shot
The FDA has faced pressure from the White House for weeks to quickly authorise a vaccine, including as recently as Friday, when White House Chief of Staff Mark Meadows told FDA Commissioner Stephen Hahn his job could be on the line if the agency did not get it done soon.
Following a vote on Thursday by an advisory panel of outside experts backing the vaccine for use in people 16 and older, the FDA was weighing how to address reports of serious allergic reactions in the UK, where the vaccine was approved earlier this month.
Officials there have since told people with a history of significant allergic reactions not to get the vaccine. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, told the advisory panel on Thursday that the FDA was seeking more information on the reactions from regulators in Britain.
Hong Kong buys 15 million Covid-19 vaccine doses from Sinovac, Pfizer
Pfizer’s vaccine, like one from Moderna Inc. that could also gain clearance next week, uses a new technology called messenger RNA that turns the body’s own cells into vaccine-producing factories to fight the coronavirus.
In a trial of almost 44,000 people, the Pfizer vaccine was 95 per cent effective at preventing symptomatic cases of Covid-19, and protected people of all ages and ethnicities. It was able to prevent the most severe infections, according to clinical trial results.
Side effects in Pfizer’s clinical trial were mild and developed more frequently in younger participants in the study, specifically those aged 55 and younger, with no signs of serious safety concerns, according to an FDA staff report on the vaccine’s safety and efficacy.
After the second injection, fatigue and headache were the most common systemic reactions, occurring in 59 per cent and 52 per cent of the younger participants, compared with 51 per cent and 39 per cent in those over age 56. Pfizer said patients in the trial did not experience serious allergic reactions.
It is unclear if the vaccine is effective at preventing Covid-19’s spread, according to the FDA staff report. It is possible the shot does not work as well at preventing cases where people do not have symptoms, meaning there is likely to be a continued need for basic public-health measures such as wearing masks and social distancing.
With initial supply very limited, the vaccine is expected to be given first to health care workers and residents of long-term care facilities.
Countries are clamouring for more doses, said Sean Marett, BioNTech’s chief business and commercial officer.
WHO wants end to ‘panic-then-forget’ approach to epidemics
“Everybody wants all their doses on January 2 of next year, but that’s not practical,” Marett said in an interview. “This is a new technology, there does not exist a manufacturing network. We are building it.”
The shot requires special freezers to be kept extra cold temperatures until a few days before use, making distribution more complicated. Pfizer has developed special dry-ice containers to make it easier to store for facilities that do not have the needed equipment.
Among the vaccine front-runners, the Pfizer-BioNTech shot is the only one that did not take funding from the White House-led Operation Warp Speed programme to accelerate development, manufacturing and distribution of Covid-19 shots. However, the two companies have secured a US$2 billion deal to supply 100 million doses to the US, with an option for 500 million more.
Additional reporting by AFP