Britain on Wednesday became the first country to approve Pfizer-BioNTech’s COVID-19 vaccine for general use and said it would be introduced next week.
“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s Covid-19 vaccine for use,” the department of health said in a statement.
“The vaccine will be made available across the UK from next week,” the statement said, with priority given to groups including nursing home residents, health and nursing home staff, followed by older adults.
Other countries aren’t far behind: The US and the European Union also are vetting the Pfizer shot along with a vaccine made by Moderna Inc.
Prime Minister Benjamin Netanyahu said last month that Israel had signed a deal with Pfizer to purchase eight million doses of the vaccine, enough to inoculate four million Israelis. Those vaccines are expected to begin arriving in Israel in the coming weeks.
Pfizer said it would immediately begin shipping limited supplies to the UK — and has been gearing up for even wider distribution if given a similar nod by the US Food and Drug Administration, a decision expected as early as next week.
But doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.
Pfizer CEO Albert Bourla called the UK decision “a historic moment.”
“We are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” Bourla said in a statement.
While the UK has ordered enough Pfizer vaccine for 20 million people, it’s not clear how many will arrive by year’s end and adding to the distribution challenges is that it must be stored at ultra-cold temperatures.
Every country has different rules for determining when an experimental vaccine is safe and effective enough to use. Intense political pressure to be the first to roll out a rigorously scientifically tested shot colored the race in the US and Britain, even as researchers pledged to cut no corners. In contrast, China and Russia have offered different vaccinations to their citizens ahead of late-stage testing.
The shots made by US-based Pfizer and its German partner BioNTech were tested in tens of thousands of people. And while that study isn’t complete, early results suggest the vaccine is 95% effective at preventing mild to severe COVID-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot.
“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO, recently told The Associated Press.
The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.
But experts caution that a vaccine cleared for emergency use is still experimental and the final testing must be completed. Still to be determined is whether the Pfizer-BioNTech shots protect against people spreading the coronavirus without showing symptoms. Another question is how long protection lasts.
The vaccine also has been tested in only a small number of children, none younger than 12, and there’s no information on its effects on pregnant women.