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FDA Advisory Panel Approves Pfizer's COVID-19 Vaccine

With this hurdle out of the way, the FDA can approve the vaccine for emergency use.
FDA Advisory Panel Approves Pfizer's COVID-19 Vaccine
Image from: iStock Photo -simon2579

The FDA's outside panel of experts has recommended the FDA approve the Pfizer COVID-19 vaccine by a vote of 17-4 with one abstention.

NBC News:

Though the FDA is not obligated to go along with the panel's recommendation, it is widely anticipated that the regulatory agency will indeed authorize the Pfizer vaccine for emergency use, and do so promptly.

"Our plan is to take their recommendations into account for our decision-making and make a decision shortly thereafter," FDA Commissioner Dr. Stephen Hahn said Thursday on the "TODAY" show. "It really depends upon the complexity of the issues discussed, but we intend to act quickly."

This is good news, but is still a tiny pinpoint of light at the end of the tunnel, especially given that the Trump "administration" took a pass on ordering more of the vaccine when they had the chance.

Before Pfizer’s coronavirus vaccine was proved highly successful in clinical trials last month, the company offered the Trump administration the chance to lock in supplies beyond the 100 million doses the pharmaceutical maker agreed to sell the government as part of a $1.95 billion deal over the summer.

But the administration, according to people familiar with the talks, never made the deal, a choice that now raises questions about whether the United States allowed other countries to take its place in line.

So right now we have 100 million doses of the vaccine, which means 50 million people can be vaccinated. That's just a light drop in a large bucket right now. Hopefully as more vaccines come online, more of us can take them.

Will you?

Update: Here is a statement from the Biden-Harris transition:

Yesterday marked another tragic milestone in our fight against COVID-19. Jill and I grieve with everyone mourning a loved one lost to this deadly virus.

But today’s approval by the Food & Drug Administration of the Pfizer-BioNTech COVID-19 vaccine is a bright light in a needlessly dark time. We are grateful to the scientists and researchers who developed this vaccine. And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point.

Vaccines don’t equal vaccinations. Our challenge now is to scale up manufacturing and distribution to distribute 100 million shots in the first 100 days of my administration. We are putting together an experienced team to do just that. Before I take office, we need the Trump Administration to purchase the doses it has negotiated with Pfizer and Moderna and to work swiftly to scale manufacturing for the U.S. population and the world. And, we will need Congress to fund our distribution efforts.

As we mark this important milestone, we know it didn’t have to be this bad. My administration will manage a robust and aggressive plan to contain this virus starting on day one. My first 100 days won’t end COVID-19, but we can and will slow the spread of the disease while we manufacture and distribute this vaccine. It will take everyone doing their part: mask wearing, social distancing, and limiting their travel over the holidays.

Together, we will find more bright lights through the dark times.

Note: Today's approval was not an FDA emergency approval. It was a recommendation by an expert advisory panel.

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