The Atlanta Journal-Constitution

What to know about Pfizer vaccine

- By Carl Zimmer and Katie Thomas The New York Times

As coronaviru­s cases surge in the United States and elsewhere, with little relief in sight, the world got good news on Monday. Pfizer and its partner, the German company, BioNTech, announced preliminar­y results that suggested their vaccine was more than 90% effective. The news buoyed spirits as the public saw a glimmer of hope. But it’s worth noting that the news is still preliminar­y, and there is much that is still not known about how well the vaccine works. And one thing remained clear: The vaccine will not come in time to rescue the world fromthe next several months, when the virus will take many more lives unless the public takes more stringent public health measures. Here’s what we know, and don’t know, about the vaccine:

What did these scientists findout?

In July, Pfizer and BioNTech initiated a late- stage clinical trial on a coronaviru­s vaccine. Half the people got the vaccine, while other half got a placebo of salt water. The companies then waited for people to get sick to determine if the vaccine offered any protection.

So far, 94 participan­ts out of nearly 44,000 have gotten sick with COVID- 19. An independen­t board of experts looked at how many of those people got the vaccine, and how many got the placebo. That early analysis suggests the vaccine is over 90% effective.

Is that a good result?

It is. The Food and Drug Administra­tion had set a bar of 50% efficacy for vaccine- makers who wanted to submit their candidates for emergency authorizat­ion. If the preliminar­y results from Pfizer and BioNTech bear out — and accurately reflect how the vaccine will work in the real world — then it’s farmore protective than that.

To get a sense of how good these results are, it’s worth considerin­g licensed vaccines that people regularly receive. On the low end, influenza vaccines are 40- 60% effective at best, because the influenza virus keeps evolving into new forms year after year. By contrast, two doses of the measles vaccine are 97% effective.

Is the Pfizer vaccine safe?

So far Pfizer and BioNTech have reported no serious safety concerns from their vaccine. Before running the current large- scale study, the companies ran smaller clinical trials starting in May that were specifical­ly designed to detect warning signs about the vaccine’s safety. They tried out four versions of their vaccine and selected the one that produced the fewest cases of mild and moderate side effects, such as fever and fatigue.

Who will get thenew vaccine first?

Pfizer’s chief executive has said that it could have 30 million to 40 million doses of the vaccine before the end of the year, enough for 15 million to 20 million people to get an initial shot and a booster three weeks later.

Exactly who will qualify for the initial doses has not been decided, but groups that are at higher risk for infection, or are more vulnerable to the virus, are likely to get priority. That could include health care workers as well as older adults and those who have risk factors like obesity or diabetes.

When will the general public be able to get it?

Pfizer has said that it will likely apply for emergency authorizat­ion in the third week of November, after it collects the two months of safety data that the FDA has asked manufactur­ers to submit. Then, the agency will consult with an outside advisory committee of experts, and may take weeks to pore over detailed data about the vaccine’s safety, effectiven­ess, and the companies’ ability to safely manufactur­e millions of doses.

The vaccine could be authorized for certain high- risk population­s before the end of the year, but that would only happen if everything goes as planned and there are no unforeseen delays.

 ?? UNIVERSITY­OF MARYLAND SCHOOLOFME­DICINE VIA AP ?? Pfizer and BioNTech have reported no serious safety concerns from their vaccine. Before the current large- scale study, the companies ran smaller clinical trials to detectwarn­ing signs about the vaccine’s safety.
UNIVERSITY­OF MARYLAND SCHOOLOFME­DICINE VIA AP Pfizer and BioNTech have reported no serious safety concerns from their vaccine. Before the current large- scale study, the companies ran smaller clinical trials to detectwarn­ing signs about the vaccine’s safety.

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