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**Hugh** · 08-12-2020, 15:03

Quote:

Pfizer’s Vaccine Offers Strong Protection After First Dose

The Food and Drug Administration’s first analysis of the clinical trial data also found that the coronavirus vaccine worked well regardless of a volunteer’s race, weight or age.

WASHINGTON — The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group.

The finding is one of several significant new results featured in the briefing materials, which include more than 100 pages of data analyses from the agency and from Pfizer. Last month, Pfizer and BioNTech announced that their two-dose vaccine had an efficacy rate of 95 percent after two doses administered three weeks apart. The new analyses show that the protection starts kicking in far earlier.

What’s more, the vaccine worked well regardless of a volunteer’s race, weight or age. While the trial did not find any serious adverse events caused by the vaccine, many participants did experience aches, fevers and other side effects.

“This is what an A+ report card looks like for a vaccine,” said Akiko Iwasaki, an immunologist at Yale University.

Quote:

The briefing materials also provide a deeper look at the safety of the vaccine. In any large clinical trial, some people who get vaccines experience health conditions that have nothing to do with the vaccine itself. Comparing their rates of symptoms with those of the placebo group as well as with background rates in a population can point to symptoms that may actually be caused by a vaccine.

The F.D.A. concluded that there were no “meaningful imbalances” in serious health complications, known as adverse events, between the two groups. The agency noted that four people in the vaccinated group experienced a form of facial paralysis called Bell’s palsy, with no cases in the placebo group. The difference between the two groups wasn’t meaningful, and the rate in the vaccinated group was not significantly higher than in the general population.

The new Pfizer analysis revealed that many volunteers who received the vaccine felt ill in the hours after the second dose, suggesting that many people might have to request a day off work or be prepared to rest until the symptoms subside. Among those between ages 16 and 55, more than half developed fatigue, and more than half also reported headaches. Just over one-third felt chills, and 37 percent felt muscle pain. About half of those over age 55 felt fatigued, one-third developed a headache and about one-quarter felt chills, while 29 percent experienced muscle pain.

“Taking a day off after the second dose is a good thing to anticipate,” Dr. Iwasaki said.

I was told the same thing about the 2nd dose I got on the trial I’m taking part in (I didn’t, so I may have had the placebo).