The panel of outside advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19.
The recommendation is non-binding but it’s a key step toward expanding the U.S. booster campaign to millions more Americans. Many people who got their initial Pfizer shots at least six months ago are already getting a booster after the FDA authorized their use last month — and those are the same high-risk groups that FDA’s advisers said should get a Moderna booster.
But there’s no evidence that it’s time to open booster doses of either the Moderna or Pfizer vaccine to everybody, the panel stressed — despite initial Biden administration plans to eventually do that.
The coronavirus still is mostly a threat to unvaccinated people — while the vaccinated have strong protection against severe illness or death from COVID-19.
“I don’t really see a need for a ‘let it rip’ campaign for everyone,” said Dr. Michael Kurilla of the National Institutes of Health.
As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster.
Moderna asks Health Canada to approve COVID-19 vaccine booster shot
The agency convened its experts to weigh in on who should get boosters and when for those who received the Moderna and Johnson & Johnson shots earlier this year. The panel will discuss J&J on Friday.
The FDA will use its advisers’ recommendations in making final decisions for boosters from both companies. Assuming a positive decision, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get one.
Many U.S. scientists remain divided about exactly who needs boosters and their purpose — whether they’re needed mostly for people at risk of severe disease or whether they should be used to try to reduce milder infections, too.
The FDA panel wrestled with whether Moderna presented enough evidence backing its low-dose booster.
As the delta variant surged in July and August, a Moderna study found people who were more recently vaccinated had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago.
Another study of 344 people found a six-month booster shot restored virus-fighting antibodies to levels thought to be protective — and that included large jumps in antibodies able to target the delta variant. But that was a small study, and only about half of those people got the exact series of doses that would be offered under a Moderna booster campaign.
Inside Moderna: Making boosters and tracking variants
“The data itself is not strong but it is certainly going in the direction that is supportive of this vote,” said Dr. Patrick Moore of the University of Pittsburgh.
And several advisers worried that boosting with a lower dose might cost people some of the potential benefit of a full-strength third shot.
“That may actually have a tremendous impact on the durability,” Kurilla said.
Moderna said it chose the lower-dose booster because it triggered fewer uncomfortable shot reactions such as fever and achiness but also leaves more vaccine available for the global supply.
One very rare side effect of both the Moderna and Pfizer vaccines is heart inflammation, particularly among young men soon after the second dose — and one lingering question is whether another dose could spark more cases. Moderna’s booster study wasn’t large enough to spot such a rare risk.
But Israel began offering Pfizer boosters sooner than the U.S. and to more of its population. Thursday, Dr. Sharon Alroy-Preis of Israel’s health ministry told the FDA panel that after 3.7 million booster doses administered, there’s no sign the extra shot is any riskier.
Because the Moderna vaccine is similar, the FDA’s advisers found that data reassuring.
While Pfizer’s boosters are only for certain high-risk groups of Americans, Israeli officials credit wider booster use in their country to stemming the delta surge.
“There is no question in my mind that the break of the curve was due to the booster dose,” Alroy-Preis said in response to FDA advisers who noted that other countries have seen a lowering of delta cases without widespread booster use.
But FDA’s advisers also highlighted one confusing issue: People with severely weakened immune systems already can get a third full dose of the Moderna vaccine soon after the initial vaccinations — so a lingering question is whether they should be eligible for a booster, too, which would be their fourth dose.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
© 2021 The Canadian Press
Netflix’s ‘Squid Game’ estimated to be worth about $900 million – Bloomberg News
“Squid Game,” Netflix Inc’s biggest original series launch, is estimated to be worth almost $900 million for the streaming giant, Bloomberg News reported late on Saturday, citing figures from an internal Netflix document.
The nine-episode thriller, in which cash-strapped contestants play childhood games with deadly consequences in a bid to win 45.6 billion won ($38.58 million), became an international hit after it launched last month.
In comparison to its estimated net worth, the show cost just $21.4 million to produce, Bloomberg said.
According to the report https://bloom.bg/3lNzxGY, about 132 million had watched at least two minutes of the show in its first 23 days, easily breaking the record set by U.K. costume drama “Bridgerton,” which was streamed by 82 million accounts in its first 28 days.
Netflix had earlier announced the show had amassed 111 million fans, but Bloomberg said those figures were based on slightly older data.
Los Gatos, California-based Netflix estimated that 89% of people who started the show watched more than one episode, the news agency said, and 66% of the viewers finished watching the series in the first 23 days.
Netflix did not immediately respond to Reuters’ request to comment on the report. An attorney for the company told Bloomberg that it would be inappropriate for Bloomberg to disclose the confidential data contained in the documents that it had reviewed.
The series is also the first Korean drama to snatch the top spot on Netflix in the United States, and has even spurred interest among people in learning Korean.
In China, where Netflix is unavailable without a VPN, a Beijing bakery has introduced a Squid Game-themed confection-making challenge in its store.
The show has even drawn positive comments from Amazon Inc founder Jeff Bezos, with the billionaire calling the work “impressive and inspiring.” Amazon’s streaming service Prime Video competes with Netflix.
($1 = 1,182.0700 won)
(Reporting by Shubham Kalia in Bengaluru, Editing by Nick Zieminski)
Bank of England will have to act to contain inflation – Bailey
“Monetary policy cannot solve supply side problems but it will have to act and must do so if we see a risk particularly to medium-term inflation and to medium-term inflation expectations,” Bailey said on Sunday.
“And that’s why we at the Bank of England have signalled, and this is another such signal, that we will have to act,” he said during a panel discussion organised by the Group of 30 consultative group. “But of course that action comes in our monetary policy meetings.”
(Reporting by William Schomberg; Editing by Alex Richardson)
UPDATE: U.S. expected to reopen border November 8, mixed doses eligible – BlackburnNews.com
UPDATE: U.S. expected to reopen border November 8, mixed doses eligible
October 15, 2021 7:25pm
There is word the U.S. will allow fully vaccinated Canadians with mixed doses of the COVID-19 vaccine to enter when the land border reopens to travellers next month.
The Centers for Disease Control and Prevention said early Friday evening that individuals who received doses of two or more different COVID-19 vaccines, including the Astra Zeneca vaccine, will be considered eligible to enter the United States starting in November.
“While CDC has not recommended mixing types of vaccine in a primary series, we recognize that this is increasingly common in other countries so should be accepted for the interpretation of vaccine records,” a statement from the agency read.
Earlier on Friday, a White House official told the Canadian Press on condition of anonymity, since the policy has not yet been made public, that the official reopening date for land borders will be November 8.
However, New York State Congressman Brian Higgins tweeted the date too.
The White House is indicating the U.S. will start allowing vaccinated Canadians to enter the U.S. through land ports of entry beginning on November 8. pic.twitter.com/dlWWZsL1wU
— Brian Higgins (@RepBrianHiggins) October 15, 2021
The Canada Border Services Agency also reminded Canadians what they would need to re-enter the country once land and water border points do open.
Travellers re-entering Canada will have to complete a PCR test within 72 hours of arriving at the border. They will also have to provide proof they are fully vaccinated against COVID-19 using the ArriveCan app.
“Antigen tests, often called ‘rapid tests,’ are not accepted,” said the CBSA statement.
For trips of less than 72 hours, Canadians and those registered under the Indian Act, permanent residents and protected persons can take their PCR test before they leave the country.
“Unvaccinated or partially vaccinated travellers who are eligible to enter Canada must continue to follow pre-arrival, arrival, and Day-8 molecular COVID-19 testing requirements, and quarantine for 14 days,” continued the statement.
Canada reopened its border to American travellers on August 9.
UN envoy says has agreement on drafting new Syrian constitution
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