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Pfizer Is Submitting Its COVID-19 Vaccine for Emergency FDA Approval Today

Pfizer Is Submitting Its COVID-19 Vaccine for Emergency FDA Approval Today

Good news alert: Pfizer is submitting its COVID-19 vaccine to the FDA, requesting emergency approval to speed up the process and begin distribution to Americans. Pfizer has evidence that the vaccine is safe and about 95 percent effective at blocking the vaccine. If all goes well, the first doses of the vaccine could be administered in mid-December, with first priority given to healthcare workers. Pfizer has 50 million pre-manufactured doses ready to go, pending approval of the CDC advisory panel.

Pfizer released results of its latest round of tests on November 18, with trial results suggesting their vaccine is 95 percent effective against the virus. This trial recruited 43,000 participants. Half got the trial vaccine, the other half got a placebo shot. 170 total participants got infected with the coronavirus, 162 of whom were in the group that got the placebo. That suggests a very high rate of effectiveness, even by the standards of normal vaccinations.

Another bonus of this vaccine? It looks like this vaccine comes with very few side effects. A little under four percent of participants reported feelings of fatigue, and about two percent reported some headaches. Those are pretty good odds for anyone who gets the vaccine and, in any case, fatigue and headaches are preferable to COVID-19 symptoms.

The promising news comes not a moment to soon for the U.S., which has been beleaguered by COVID-19 since March as the pandemic has outmatched federal attempts at containment nearly all year. With over eleven million cases and over a quarter of a million deaths, healthcare officials have been eagerly anticipating a vaccine as a crucial element in the fight against COVID-19. The federal government poured ten billion dollars into Operation Warp Speed in an attempt to speed up the hunt for a vaccine, which has led to no less than four vaccine contenders in late stage development.

Pfizer was not a part of Operation Warp Speed and has actively attempted to distance itself from the Trump Administration’s efforts, although it did agree to a nearly two billion dollar distribution agreement with the government in the event of approval.

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