UK first country to authorize Pfizer COVID-19 vaccine for emergency use

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By KYW Newsradio and Associated Press

PHILADELPHIA (KYW Newsradio) -- The United Kingdom became the first country to authorize Pfizer's COVID-19 vaccine for emergency use. The rollout is expected to begin as early as next week.

The Medicines & Healthcare Products Regulatory Agency, which licenses drugs in the U.K., gave the approval on Wednesday for the first shot against the virus backed by rigorous science, taking a major step toward eventually ending the pandemic.

“Today’s emergency use authorization in the U.K. marks a historic moment in the fight against COVID-19,” Pfizer chairman and CEO Albert Bourla said. “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.”

The go-ahead for the vaccine developed by American drugmaker Pfizer and and its German partner BioNtech comes as the virus surges again in the United States and Europe, putting pressure on hospitals and morgues in some places and forcing new rounds of restrictions that have devastated economies.

U.K. Health Secretary Matt Hancock said 800,000 doses will be available as the country begins vaccinations next week.

“For so long, we’ve been saying that “if” a vaccine is developed then things will get better in 2021. And now we can say “when” this vaccine is rolled out things will get better,” Hancock said to the BBC.

Pfizer and BioNtech say clinical trials show the vaccine to be 95% effective. They say that the vaccine also offers significant protection for older people, among those most at risk of dying from the disease.

Overall, the U.K. ordered 40 million doses of the two-shot vaccine, enough for 20 million people.

Doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.

And there are logistical challenges in the way of distributing the vaccine, because it must be stored at the ultra-cold -94 degrees Fahrenheit.

A government committee will release details of the U.K.'s vaccination priorities later Wednesday, but Hancock said medical workers and people in nursing homes and long-term care facilities will have access to the vaccine first.

In the United States, the CDC's Advisory Committee on Immunization Practices on Tuesday approved similar recommendations for states to follow when the vaccine becomes available in the U.S.

Regulators in the United States and the European Union also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna Inc. British regulators also are considering another shot made by AstraZeneca and Oxford University.

Pfizer said it would immediately begin shipping limited supplies to the U.K. — and has been gearing up for even wider distribution if given a similar nod by an FDA advisory committee of independent medical experts who will be discussing emergency use authorization on Dec. 10.

CNN, citing document it obtained from the White House's Operation Warp Speed, reports the first doses could be delivered as early as Dec. 15, with the Moderna vaccine delivered a week later.

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 U.S. 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.

Pfizer and BioNtech also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.

The vaccine remains experimental while final testing is done. 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 in pregnant women.

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