Two vaccine makers reveal their secret blueprints
Drug companies making vaccines have been under increasing pressure from independent scientists and public health experts to be more transparent about how they are running their clinical trials.
But none of the nine companies that are testing vaccines in late-stage clinical trials had released detailed blueprints — until today.
Moderna became the first to release detailed protocols for its vaccine trials, and hours later Pfizer followed suit. The disclosures are aimed at addressing growing suspicion among Americans that President Trump’s drive to produce a vaccine before the election on Nov. 3 could result in a product that was unsafe.
Moderna and Prizer revealed how trial participants were selected and monitored, what kinds of problems would prompt the trials to be stopped early, and the evidence researchers would use to determine whether people who got the vaccine were protected from the coronavirus.
AstraZeneca, another leader in the race for a vaccine, did not respond to inquiries about whether it would now disclose its study protocol.
Our reporters are still reviewing Pfizer’s disclosures. Here are a few highlights from Moderna’s:
The blueprint suggests that the first analysis of the trial data may not be conducted until late December, though company officials now say they expect the initial analysis in November. Even so, later analyses in the spring may be needed.
Read more about the disclosures here. We also answered questions about when you might be able to be vaccinated.
Locking down Israel, again
During the country’s initial outbreak in the spring, Israel managed to limit the spread of the virus with containment measures. But after a quick end to the lockdown, the virus has come roaring back: The country has one of the worst infection rates in the world.
Now Israel is about to become one of the few places in the world to enter a second lockdown, set for Friday, the start of Rosh Hashana, the Jewish New Year.
To prevent large family gatherings that could become petri dishes for the virus, people will be required to stay within about 600 yards of their homes. But there are lots of exceptions: work, exercise, to protest, to buy essentials or to fulfill a variety of religious obligations.
Many Israelis are questioning the logic behind the complex rules.
The exemptions are particularly upsetting for secular Israelis. Swimming pools are closed, but Jewish women will be allowed to travel farther than 600 yards for a dip in a ritual bath. Cultural venues, museums, gyms and hotels will be shut, but synagogues will remain open.
The result, our colleague Isabel Kershner told us, is an atmosphere that is more despairing than joyous for the holiday.
“People are quite sad,” Isabel said. “You already had Passover under the first lockdown, in April, and I think people then just couldn’t imagine that we would still be not only in the same place — but worse, by September. There is a very depressed and sad feeling about this.”
Here’s a roundup of restrictions in all 50 states.
What else we’re following
What you’re doing
I work at home at a desk in the middle of my living room. As the school year started, my kids were not always quiet as they passed through. So I decided to create the idea of an office door. I made a sign that leans against the lamp on my desk that reads: “In the Office: Focus Required. Please ‘knock’ before ‘entering.’” Now, if I’m at my desk, my kids play along by either knocking on a nearby wall or saying, “Knock knock, Mom,” to ask if it’s OK to interrupt. So far, it’s working out pretty well.
— Tami Booth Corwin, Bucks County, Pa.
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Lara Takenaga contributed to today’s newsletter.
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