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On Tuesday, Dec. 8, federal health officials said that initial trials of the vaccine have proven it is highly effective after the first dose, though it will still require a second dose 21 days later for complete vaccination.
According to reports, the first dose becomes effective within approximately 10 days as the FDA prepares for a meeting of its vaccine advisory group this week. It has also been equally effective regardless of race, weight, or age.
The FDA released more than 100 pages of new data that will be discussed on Thursday, Dec. 10 by officials to determine whether they recommend authorizing the vaccine.
New COVID-19 cases tapered off in the vaccinated group of volunteers approximately 10 days after the first dose, according to one graph in the materials.
Officials cautioned that it is unclear how long protection from the first dose would last on its own until a second can be administered.
The FDA found no “meaningful imbalances” in serious health complications in those who volunteered to be tested. The agency noted that four people in the vaccinated group experienced a form of facial paralysis, with no cases in the placebo group during the study.
The Pfizer analysis revealed that many volunteers who received the vaccine felt ill in the hours after the second dose.
Among those between ages 16 and 55, more than half expressed that they experienced fatigue, and more than half reported headaches. Approximately one-third felt chills, and 37 percent felt muscle pain. Roughly half of the volunteers over the age of 55 felt fatigued, a third developed a headache a quarter of the volunteers felt chills, and 29 percent experienced muscle pain.
“Based on the totality of scientific evidence available, it is reasonable to believe that the Pfizer COVID-19 vaccine may be effective in preventing COVID-19 in individuals 16 years of age or older,” researchers found. “The known and potential benefit of the vaccine outweigh its known and potential risks for use in individuals 16 years of age and older.”
Pfizer has headquarters in Rockland County and New York City.
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