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Fwd: Coronavirus: The F.D.A. rules on boosters



---------- Forwarded message ---------
From: The New York Times <nytdirect@nytimes.com>
Date: Fri, Sep 17, 2021, 6:09 PM
Subject: Coronavirus: The F.D.A. rules on boosters



The F.D.A. approved boosters for people 65 and older or at high risk of severe Covid.
Coronavirus Briefing

September 17, 2021

An informed guide to the pandemic, with the latest developments and expert advice about prevention and treatment.

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The New York Times

Boosters for older Americans

After weeks of heated debate, an F.D.A. advisory panel voted against approving a booster shot for people 16 and older who received the Pfizer-BioNTech vaccine. The panel did recommend a booster for Pfizer-BioNTech recipients who are 65 or older, or are at high risk of severe Covid-19.

The negative vote was a setback for President Biden's booster plan, which, as we described yesterday, has come under fire from some experts. The White House wanted most adults who had received a second Pfizer or Moderna vaccine dose to start receiving booster shots next week, in a plan that was announced before obtaining F.D.A. approval.

The votes followed hours of presentations by officials from Pfizer, the C.D.C., the Israeli government and independent experts on the complex array of data about the effectiveness of the Pfizer vaccine over time.

The independent experts on the panel challenged whether the data justified a broad rollout of extra shots when the vaccines appear to still offer robust protection against severe disease and hospitalization, at least in the U.S.

Although the F.D.A. is not required to follow its advisory committee's recommendations, it typically does. The agency will most likely make a final decision by early next week.

Requiem for a weird vax summer

Our second pandemic summer has come to a close on a bittersweet note, although the warm weather may last a while longer.

To get a sense of how things shook out, we talked to Michael Gold and Julia Carmel, our colleagues who co-wrote the Summer in the City newsletter. (Here's their last edition.) They've been up close and personal with New York City's chaotic, beautiful and uneven return to fun.

What was the energy like this summer?

JULIA: In the beginning of the summer, there was this feeling of: "We did it. We made it! We get to dance with our friends. We can go make out with strangers!" It was this feeling of pure chaos.

MICHAEL: There was this feeling that life would go back to normal, except that it was warm. We'd pick up where we left off in February 2020. There were all these predictions of, "It's going to be a bacchanal in the city." For a while, it felt like that. People were out. Everyone was doing their thing, everyone was outside, everyone was ready to have fun.

There was this sense of: "I have to go out now. If I don't go out now, what was all that for?"

What were parties like in terms of virus regulations?

JULIA: You are talking to two queer reporters who live in New York City, so we do have a bias. The center of gay New York nightlife, that peaked around Pride. In June, there were the test parties.

There were some events where people were keeping their masks on. There were some events where it was entirely outside. There were different ways that people were finding their sweet spot of, "This feels like a party, and I feel safe."

I don't think it was as simple for everyone as: "I'm vaccinated, I'm taking off my mask and I'm going into the warehouse."

When did things start to change?

MICHAEL: July was when things started to get a little rocky. We started to hear about all these breakthrough cases, especially in Provincetown, Mass. There was a sense that vaccination was not a get-out-of-jail-free card anymore.

That's when you'd start talking to people and say, "Hey, are you going to this thing?" And they'd say: "I don't know. I'm going to see my parents in a week and now the Delta variant is here. I'm not going to go." That was a very last-summer energy to bring to the table.

In July, it was like: "Actually, no. The existential threat of this virus still remains." The energy changed from being carefree, happy-go-lucky-whatever to being a little more: "Maybe the world is burning. Let's have fun while it does."

How did you stay safe covering nightlife?

JULIA: After being so long in the house, there's this feeling of weighing risks and being like, "I deserve more joy over trauma, as long as that is not hurting someone else."

MICHAEL: We're two people who, after writing a newsletter all summer and agonizing about how to give people summer recommendations responsibly, have reached the conclusion: We're vaccinated and hoping for the best.

What do you think fall will look like?

MICHAEL: I will continue to find excuses to drink on boats outside while the weather is still nice. I hesitate to make predictions with the virus because if you had asked me in May what I thought the summer was going to be like, I would have been wrong.

But I will say that reports of summer's end have been wildly exaggerated. Julia and I are going out tonight to a party where vaccinations will be required.

For two great pieces on parties:

How your summer went

We asked you about your own summers and received hundreds of responses. Thanks to everyone who wrote in. Here's a selection:

"I live in Florida. (Enough said, right?) I managed two in-theater movies, one indoor dinner and a night out at a crowded bar before I went back inside my house and bolted the door. I'm vaccinated, but you don't roll the dice with the numbers we had in July and August. My out-of-state friends found very polite ways to request I cancel my visits. It sucked to taste the good life and then have it pulled out from underneath you." — Michael Coccagnia, Tampa, Fla."As the summer began, we were still basking in the glow of having been vaccinated. We had couples over for dinner inside. We hosted overnight guests. We spent time with our grandchildren and their parents. We even made a five-day, 2,500-mile drive across the country to see family and stayed in motels along the way. It was a good summer — almost normal. Then Labor Day weekend, we had drinks on the porch with family and the next day they tested positive. A week later, so did I." — Jessica Crist, Great Falls, Mont."At the beginning of the summer, I mailed out wedding invitations for what was supposed to be a chance to finally celebrate my marriage. By August, I was calling family members across the country to un-invite them to our significantly scaled-down, all-outdoor wedding. Our honeymoon plans are canceled. Our hearts are broken — again. This is not how we thought our first year as newlyweds would go." — Danielle Currie, Cinnaminson, N.J."The weekend of Seattle Pride, I found out that some gay bars were allowing folks with vaccine cards to come in and mingle and mix without masks. It was simultaneously anxiety-inducing and intoxicating. As the summer carried on, I found myself going to dance clubs where there were vaccine checks at the door. Sweating, shirtless, in the middle of the club to Lady Gaga and Ariana Grande's 'Rain on Me' was a highlight of the summer. And then Delta came along and the governor pulled the plug on indoor gatherings. Which I totally support, by the way." — Daniel Goodman, Seattle."After what felt like a long and dark winter, the Danish spring and summer was a relief in more than just one way. Unlike many other countries, vaccine hesitancy is not much of an issue in Denmark. On the contrary, one of the key words through the pandemic here was 'samfundssind' — a sense of what's best for the community. Due to high vaccination rates, all restrictions in the country were lifted. My personal culmination was to attend the first full-scale rock concert since the start of the pandemic alongside 50,000 others, representing roughly 1 percent of Denmark's population. What a night. What a relief. Bit scary though, nevertheless." — Jens-Ove Schmidt, Denmark

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