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Pfizer Set to Request Authorization for Coronavirus Booster for 16- and 17-Year-Olds
As President Biden exhorts Americans to get coronavirus vaccines and booster shots to strengthen protections against the Delta and Omicron variants, another age group might soon become eligible for the boosters: 16- and 17-year-olds.
Pfizer and its partner BioNTech are expected to ask the Food and Drug Administration in the coming days to authorize its booster shot for that age group, according to two people familiar with the situation.
The move to expand eligibility among teens comes as the White House is grappling with the Omicron variant that has captured the world’s attention.
Slovenia Set to Ban Janssen Vaccine After Woman’s Death
Slovenia said on Tuesday it may ban Johnson & Johnson‘s (JNJ.N) Janssen COVID-19 vaccine except when people request it, after concluding a young woman’s death was linked to the shot.
Slovenia temporarily suspended the Janssen vaccine, one of several it was using, after the death of the woman whom a neurologist said at the time had developed blood clots and bleeding in the brain. read more
“A commission established to examine the case of the death unanimously concluded that the tragic outcome was related to the vaccine,” commission member Zoran Simonovic was quoted as saying.
Researchers Review COVID Database, Make a Huge Discovery When They Exclude Vaccinated People
A new study touts the power of natural immunity to fight off the worst effects of the coronavirus. The researchers, who reported their results last week in the New England Journal of Medicine, examined 353,326 COVID-19 patients in the Arabian Peninsula nation of Qatar who were infected anywhere between Feb. 28, 2020, and Apr. 28, 2021.
The research excluded about 87,500 people who were vaccinated over the time span of the study. “In earlier studies, we assessed the efficacy of previous natural infection as protection against reinfection with SARS-CoV-2 as being 85% or greater,” the researchers, from Qatar’s National Study Group for COVID-19 Epidemiology, wrote.
“Accordingly, for a person who has already had a primary infection, the risk of having a severe reinfection is only approximately 1% of the risk of a previously uninfected person having a severe primary infection.”
All Vaccinated Adults Should Get a COVID Booster Shot Because of the Omicron Variant, CDC Says
The U.S. Centers for Disease Control and Prevention (CDC) strengthened recommendations for booster doses of coronavirus vaccine Monday, saying all adults should get boosted 6 months after the second dose of Pfizer/BioNTech’s or Moderna’s vaccine or 2 months after the single dose Johnson & Johnson vaccine.
It’s a slight but significant tweak to the wording of guidance issued earlier this month when the CDC endorsed an expanded emergency use authorization for boosters from the U.S. Food and Drug Administration.
New Omicron Variant Could Spell End for COVID Pandemic — Top Russian Scientist
A new mutant strain of COVID-19 that has sparked fears for vaccine resistance, caused flight cancellations, and sent the stock market plummeting could actually help bring the pandemic to an end, a Russian virologist has claimed.
In an interview published on Monday in Moscow tabloid KP, Anatoly Altshtein, a virologist at the Gamaleya Research Institute of Epidemiology and Microbiology, which pioneered Russia’s Sputnik V jab, said that there it is still not clear how deadly or infectious the new Omicron variant might be.
“Right now there are reasons to think that the Omicron variant could be less pathogenic,” he went on, meaning less able to cause harmful infection.
Biden Says He Will Direct FDA, CDC to Use ‘Fastest Process Available’ to Clear COVID Vaccines Targeting Omicron
President Joe Biden said Monday he is directing federal agencies to be prepared to move as quickly as possible to approve additional vaccines or boosters tailored to shield against the new Omicron coronavirus variant.
The White House is also directing the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention to use the “fastest process available without cutting any corners” to approve those potential vaccines and get them on the market, Biden said.
A New COVID Vaccine Wasn’t Needed for Beta or Delta. What About Omicron?
Drugmakers are racing to develop new vaccines intended to target the Omicron variant, a coronavirus strain that has mutations that suggest it could evade immunity provided by vaccination or natural infection.
Moderna Chief Medical Officer Dr. Paul Burton said in an interview on NBC News Now’s “Hallie Jackson Now” on Monday that the company has already started work on a version of its vaccine to address the new variant.
Pfizer and BioNTech said they could develop an Omicron-specific vaccine within 6 weeks and ship initial batches within 100 days if needed. Johnson & Johnson also said it is pursuing a modified vaccine and will progress it as needed.
Panel Weighs Safety, Effectiveness of Merck’s COVID Pill
Government health advisers on Tuesday weighed the benefits and risks of a closely watched drug from Merck that could soon become the first U.S.-authorized pill for patients to take at home to treat COVID-19.
The Food and Drug Administration asked its outside experts whether the agency should authorize the pill, weighing new information that it is less effective than first reported and may cause birth defects. A vote was expected Tuesday afternoon. The panel’s recommendations aren’t binding but often guide FDA decisions.
Another question is whether pregnant women or women of child-bearing age should avoid the drug. FDA scientists said Tuesday that company studies in rats showed the drug caused toxicity and birth defects in the skeleton, eyes and kidneys.
Pfizer CEO Is ‘Very Confident’ the Company’s Oral COVID Pill Will Be Effective Against the New Variant
Pfizer CEO Albert Bourla said he believes his company’s COVID-19 oral treatment will work in patients diagnosed with the Omicron variant.
“I’m very, very confident that this drug works for all known mutations, including the Omicron one,” Bourla said on CNBC’s Squawk Box. “But we are working on other drugs for the eventual case that maybe a resistance is developed.”
Bourla said that Pfizer designed the pill to work regardless of the virus’s mutation.
U.S. Tracking of Virus Variants Has Improved After Slow Start
After a slow start, the United States has improved its surveillance system for tracking new coronavirus variants such as Omicron, boosting its capacity by tens of thousands of samples per week since early this year.
Viruses mutate constantly. To find and track new versions of the coronavirus, scientists analyze the genetic makeup of a portion of samples that test positive.
It’s a global effort, but until recently the U.S. was contributing very little. With uncoordinated and scattershot testing, the U.S. was sequencing fewer than 1% of positive specimens earlier this year. Now, it is running those tests on 5% to 10% of samples.
Regeneron’s COVID Antibody Drug May Be Less Effective Against Omicron
Regeneron Pharmaceuticals Inc’s COVID-19 antibody drug could be less effective against Omicron, it said on Tuesday, adding to fears about the efficacy of existing treatments after Moderna‘s top boss raised similar concerns about the company’s vaccine.
Based on its study of Omicron’s individual mutations, “there may be reduced neutralization activity of both vaccine-induced and monoclonal antibody conveyed immunity”, Regeneron (REGN.O) said, adding that the analysis included its COVID-19 antibody cocktail, REGEN-COV.
