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US Approves Coronavirus Vaccine for Emergency Use

FILE - A vial of the Pfizer/BioNTech COVID-19 vaccine is seen ahead of being administered at the Royal Victoria Hospital, on the first day of the largest immunisation programme in the British history, in Belfast, Northern Ireland December 8, 2020.
FILE - A vial of the Pfizer/BioNTech COVID-19 vaccine is seen ahead of being administered at the Royal Victoria Hospital, on the first day of the largest immunisation programme in the British history, in Belfast, Northern Ireland December 8, 2020.

The United States has approved the use of a coronavirus vaccine, a landmark development in a country where COVID-19 has killed more than 295,000 people, according to Johns Hopkins University’s Coronavirus Research Center.

The Food and Drug Administration late Friday approved Pfizer’s vaccine, developed with German partner BioNTech, for emergency use.

Inoculations are expected to begin within days, with health care workers and elderly people in long-term care facilities set to receive the first shots, when the first round of 2.9 million doses becomes available this month.

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FDA chief Stephen Hahn said at a news conference Saturday just outside Washington he would get inoculated as soon as the vaccine is available.

"With this authorization, we know that our federal partners are already moving to distribute the first doses of the vaccine throughout the country," Hahn said.

Hahn defended the fastest-ever U.S. vaccine approval process, maintaining the agency did not prioritize speed over safety.

Hahn said news accounts that White House Chief of Staff Mark Meadows threatened to fire him on Friday if the agency did not authorize the vaccine for use by a certain date were inaccurate.

Meadows’ reported warning to Hahn came on the same day President Donald Trump denounced the FDA on Twitter as a “big, old, slow turtle” and called on Hahn to “get the dam vaccines out NOW.”

The vaccine was 95% effective in preventing COVID-19 in a late-stage trial.

BioNTech Chief Executive Ugur Sahin said the vaccine “will help to save lives across the United States and could accelerate a return to normality.”

Pfizer said it would begin shipping the vaccine immediately while state public health agencies have been planning to begin administering shots as early as Monday.

The U.S. federal government is planning to accelerate vaccinations in the weeks ahead, particularly if a vaccine from Moderna, Inc. is approved soon. A U.S. Centers for Disease Control and Prevention advisory group meets Saturday to recommend whether groups like pregnant women and 16-year-olds should be vaccinated.

The top U.S. infectious disease expert, Dr. Anthony Fauci, said on Thursday that regulators and drug makers will begin clinical trials in January, testing the safety of vaccines on pregnant women and young people.

Those two groups were excluded from initial trials until researchers could determine if the vaccine was relatively safe in healthy adults before testing it on more vulnerable groups.

The Pfizer/BioNTech vaccine was approved as cases are surging in the U.S. Thousands of people are dying daily, while intensive medical care units across the country are approaching capacity, threatening to overwhelm healthcare systems.

The vaccine was first approved in Britain earlier this month, and British residents began receiving vaccinations on Tuesday. Canada also approved the vaccine and expects to begin inoculations in the coming days.

Bahrain, Mexico and Saudi Arabia have also authorized the use of the Pfizer vaccine.

Trump late Friday hailed the development as “a medical miracle.”

In a video message posted on Twitter, Trump said the first doses of the vaccine will be administered “within 24 hours” and will be “free [of charge] for all Americans.”

The president said the vaccine “will save millions of lives and soon end the pandemic once and for all.” The assertion contradicted health officials who note that it will be months before many Americans can be inoculated and that eradication of COVID-19 is far from assured.

There was no immediate reaction from President-elect Joe Biden, who earlier this week promised that 100 million vaccine doses would be administered in the first 100 days of his administration. Biden will be sworn in January 20.

The top Democrat in Congress, House Speaker Nancy Pelosi, said “Americans should have full confidence in this vaccine knowing that it has been reviewed and recommended by the independent experts of the FDA’s advisory panel.”

In a statement, Pelosi urged federal action to accelerate vaccine manufacturing, adding, “we must ensure that the vaccine will be free and distributed in a fair and equitable manner to as many Americans as possible as soon as possible.”

Health and Human Services Secretary Alex Azar, meanwhile, said millions of vaccine doses are being shipped but that, despite the good news, Americans must “double down” on public health measures.

“As Americans get vaccinated, we need to continue taking steps like washing our hands, social distancing, and wearing face coverings to protect ourselves, our loved ones, and our communities,” Azar said in a statement.

The chairman of the Senate Health Committee, Tennessee Republican Lamar Alexander, tweeted that the American public should be “grateful to the scientists in pharmaceutical companies and the federal government who produced this result, both the Trump Administration for leading it and Congress for funding it.”

Infectious Diseases Society of America President Dr. Barbara Alexander said in a statement Saturday that guidance from the Centers from Disease Control’s immunization advisory committee “will be critical to ensuring fairness, efficiency and trust in the process to follow.”

“Plans for the vaccine’s distribution must be open and consistent with the public health needs of communities across the nation awaiting this vaccine,” Alexander added. “Significant increases in funding to ensure equitable allocation and administration as well as education to build vaccine confidence will be essential to seizing this moment.”

Dr. Fauci said if distribution of the vaccine is effective and enough people get vaccinated, relief from the coronavirus crisis in the U.S. may be on the horizon.

“By the end of summer or end of third quarter, we may actually have enough herd immunity protecting our society,” he said.