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The federal government is expected to take a major step this week toward offering booster doses to a much wider range of Americans as Food and Drug Administration advisers meet Thursday and Friday to discuss the recipients of the Johnson & Johnson and Moderna awards coronavirus vaccines.
So far, regulators have only allowed booster shots for some adults who have received the Pfizer-BioNTech vaccine – a source of frustration for government medical advisers, who asked at a meeting last month whether recipients of other injections were excluded.
But the Biden administration is eager to strengthen the protection provided by the three vaccines. And federal officials have become increasingly concerned, especially for the more than 15 million Americans who have received the Johnson & Johnson vaccine, which is less effective than others.
The FDA Vaccine Expert Advisory Panel Thursday will discuss safety and efficacy data for booster injections for Moderna recipients. On Friday, the group will discuss the Johnson & Johnson boosters. The agency usually makes its decisions a few days after the advisory committee meetings.
The panel of experts will also hear a much-anticipated presentation on Friday from scientists at the National Institutes of Health on the effectiveness of mixing different brands of vaccines.
Dr Peter Marks, the FDA’s main vaccine regulator, suggested last week that federal officials favor additional shots for all three vaccines. “The data seems to show that the booster injections appear necessary,” he said.
The deliberations come as coronavirus cases in the United States are on the decline, with the seven-day average of new daily cases falling below 100,000 for the first time since early August. Hospitalizations and deaths are also on the decline.
Dr Anthony S. Fauci, the country’s top infectious disease doctor, said in an interview with CNN on Sunday that “we have to be careful not to declare victory prematurely,” citing the potential for the virus to rebound among Americans. not vaccinated.
Dr Fauci said vaccinating young children could offer another crucial line of defense. As early as Halloween, the FDA could authorize the Pfizer-BioNTech vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States.
Although the federal government has been insisting for months that all three vaccines are very effective, a recent study by the Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine was only 71% effective against hospitalization of Covid-19, compared to 88% for the two-dose Pfizer-BioNTech vaccine and 93% for the moderna regimen two-dose vaccine.
Last month Johnson & Johnson announced that a second dose, given two months after the first, boosted the effectiveness of the symptomatic Covid-19 vaccine to 94%. The company also said two injections were 100% effective against serious illnesses, although this estimate was less conclusive.
Those eligible for Pfizer’s recall include people 65 years of age and older and those who live in long-term care facilities, have underlying health conditions, or are at greater risk of exposure to the virus due to their work or their institutional environment, a group that includes health workers, teachers and inmates.
The FDA and CDC are expected to come up with essentially the same criteria for Moderna and Johnson & Johnson booster shots, although they can also discuss whether to expand eligibility to include more middle-aged people.
SYDNEY, Australia – With enthusiasm and caution, Sydney emerged from lockdown on Monday after more than 100 days of Delta’s diminished existence.
It was “freedom day”, with rules. In the state of New South Wales, where Sydney is located, up to 10 vaccinated people could congregate at home, with the number rising to 100 for weddings and 500 for outdoor events. Bars and restaurants have also opened with mandatory masks inside when people are not eating and drinking.
But with more than 70% of the state’s adult population fully vaccinated, the first sips of normalcy were more than enough to celebrate.
“People can call him on the day they want to call him,” said Dominic Perrottet, the prime minister of the state, who accidentally sprayed with beer as he tapped a keg to commemorate the occasion. “I just think this is a great day for the people of our state based on the efforts and sacrifices that everyone has made.”
For a country that was a capital of the ‘Covid zero’ strategy to completely eliminate the virus, this has been a heartbreaking metamorphosis. When the outbreak began in June, Australia was in short supply of both emergency and vaccine supplies. New cases have skyrocketed to 1,500 a day. Today, after months of public compliance, the number of cases has dropped to around 500 a day and many epidemiologists believe the country is on track to fully immunize 90 percent of its population, if not more.
Given the promising figures, Perrottet quickly accelerated the lifting of the restrictions. He recently granted an exemption that will allow 10,000 vaccinated fans to attend Sydney’s The Everest horse race. He also pushed to reopen international travel as early as next month.
Progress is still uneven. Some regional communities have much lower vaccination rates. Melbourne, Australia’s second largest city, is still locked up, with the number of cases hovering around 1,500 per day. And in Western Australia, which has lived Covid-free for most of the pandemic, only about half of adults are fully vaccinated, meaning residents of Sydney may be able to reach New York before they can visit. Perth due to state border restrictions.
But traveling is just one of the joys people can’t wait to experience. Lounges have been popular – some opening at 12:01 am, when they were permitted. Gyms also suddenly came to life early Monday morning, and even the most mundane activities seemed to be welcome.
Alexis Phitidis, owner of a mattress store in east Sydney, texted vendors and friends with only a minute left before it reopened. Inside, half a dozen customers lay down on mattresses to test out what they wanted to buy.
“It’s busy but quiet,” Phitidis said. “People are just grateful for the opportunity – we are all grateful for the opportunity to just get involved.”
A customer suddenly rushed over. He offered three words that captured the mood: “This is really great.”
Merck said Monday it submitted a request to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid.
Approval for the drug, molnupiravir, would be an important step in the fight against the coronavirus, experts said, as a convenient and relatively inexpensive treatment could reach many more high-risk people with Covid disease than the bulky antibody treatments currently in use.
The Biden administration is preparing for an authorization that could arrive in a few weeks. If approved, the pill will likely be allocated to states, as was the case with vaccines. States could then distribute the pills as they wish, for example in pharmacies or doctor’s offices, senior administration officials said.
If the pill gets cleared, tens of millions of Americans will most likely be eligible to take it if they fall ill with Covid – far more than the offer could cover, at least initially. The federal government has placed an advance order for enough pills for 1.7 million Americans, at a price of about $ 700 per patient. That’s about a third of the price the government pays for monoclonal antibody treatments, which are typically given by intravenous infusion.
Merck, which is developing the pill with Ridgeback Biotherapeutics of Miami, hopes to be able to produce enough pills for 10 million people by the end of this year. Governments have ran to lock supplies since strong clinical trial results were released this month; Australia, Malaysia, Singapore and South Korea have all announced deals.
An antiviral pill in development by Pfizer and another by Atea Pharmaceuticals-Roche will report study results in the coming months and, if effective, could increase supply.
The Merck pill is intended to be taken at home as four capsules twice a day for five days, for a total of 40 pills. This hospitalizations and deaths halved in a clinical trial that recruited unvaccinated adults who had started showing symptoms of Covid within the previous five days and were at high risk for poor disease outcomes.
Merck said it was seeking permission to administer its pill only to high-risk adults, who in the clinical trial were most often people over the age of 60 or younger with obesity, diabetes or cardiac disease.
It was not clear whether the treatment would be available to those vaccinated, who were not eligible for the clinical trial. A spokesperson for the company said it would be up to the FDA to decide.
Originally tested for the flu, the drug works by preventing the coronavirus from replicating by inserting errors into its genetic code.
This mechanism is likely to render a high-risk group, pregnant people, ineligible to receive the pills if they are allowed, for fear that the drug will cause mutations that could lead to birth defects. In the clinical trial, volunteers had to agree to refrain from unprotected sex for four days after they finished taking the pills, and some women of childbearing age had to have a negative pregnancy test to enroll in the pills. ‘study.
Sheryl Gay Stolberg contributed reporting.
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