A woman receives a moderna coronavirus (COVID-19) vaccine booster at a vaccination center in Antwerp, Belgium, on February 1, 2022.
Joanna Guerron | Reuters
of U.S. Food and Drug Administrationindependent advisory board on Thursday Recommended or Updated Covid Shot One of the autumn/winter targets Variant of XBB,Currently The nation’s major virus strains.
Advisors also generally agreed that new shots should specifically target a subspecies called XBB.1.5. The panel only discussed the selection of that particular strain and did not vote on this issue.
As of early June, XBB.1.5 accounted for nearly 40% of all Covid cases in the United States, according to the WHO. data From the Centers for Disease Control and Prevention. Its proportion has been steadily declining, and associated cases of his XBB.1.16 and XBB.2.3 variants are increasing.
“1.5 looks good,” said Dr. Melinda Wharton, senior official at the National Center for Immunization and Respiratory Diseases. Stated. “The vaccines we can use are the vaccines we have available, so it feels like a good choice,” she said.
FDA generally follows advisory committee advice, but is not required to do so. It is unclear when the agency will make a final decision on the stock selection.
There is also uncertainty about which age groups the FDA and CDC will target We encourage you to pick up your latest shots this fall.
But the committee’s recommendation has already been a win for Pfizer, Moderna and Novavax. Carrying out initial tests Prior to the meeting, we talked about each XBB.1.5 shot.
“Novavacs expects its protein-based monovalent XBB COVID-19 vaccine to be ready for commercial supply this fall, in line with today’s plans.” [advisory committee] We highly recommend it,” said John Jacobs, the company’s president and CEO.
The United States is expected to shift vaccine distribution To private company this fall. That means vaccine manufacturers will start selling vaccines. novel coronavirus Offer products directly to healthcare providers and compete for commercial market share.
The Panel’s recommendations are consistent with far-reaching changes in how the pandemic will affect the country and the world at large.
The number of people infected with the new coronavirus and those who died Dropped Government to new lows rolled back There are strict health mandates such as masks and social distancing that many believe. the pandemic is over not at all.
But Dr. Peter Marks, director of the FDA’s Vaccines Division, said the FDA “doesn’t want to wait until the virus evolves further, the public’s immunity is further weakened, and while we move indoors for the winter, we’ll be able to do it again in the United States.” I am worried that a new coronavirus wave will come.” . ”
Dr. David Kaslow, a senior official with the FDA’s Vaccines Division, said the regularly updated Covid-19 vaccine to target frequently circulating variants restores protective immunity against the virus.
This is a similar approach to how stocks are selected. annual flu vaccination. Researchers are evaluating circulating virus strains to estimate which strains will be most prevalent in the upcoming fall and winter.
But it’s unclear how many Americans will roll up their sleeves for the latest photos later this year.
just about 17% of the US population About 56 million people have received booster therapies from Pfizer and Moderna since they were approved in September, according to the CDC.
More than 40% of adults over the age of 65 experience an immune-enhancing effect from these vaccines, while the proportion in younger adults and children ranges from 18% to 20%.
These boosters were bivalent, meaning they targeted the original strain of novel coronavirus and Omicron subvariants BA.4 and BA.5.
During the conference, Pfizer, Moderna and Novavax presented preliminary data on the latest versions of their shots designed to target XBB variants.
Moderna is evaluating shots targeting XBB.1.5 and XBB.1.16, said Rituparna Das, the company’s vice president of coronavirus vaccines. XBB.1.5 and XBB.1.16 are said to be descendants of another infectious Omicron.
According to Das, preclinical data in mice show that monovalent vaccines targeting XBB.1.5 are now more prevalent than approved bivalent vaccines targeting BA.4 and BA.5. It suggests that it provokes a stronger immune response to the XBB variant.
He added that data from clinical trials involving more than 100 people also show that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All study participants had previously received four doses of the novel coronavirus vaccine.
Das said the comprehensive protection against the XBB strain was likely due to the low number of unique mutations among the mutants, which meant that the mutants were similar in composition.
There are only three unique mutations between variants XBB.1.5 and XBB.1.16, said Darrin Edwards, Moderna’s COVID-19 vaccine program leader. By comparison, he has 28 mutations between Omicron BA.4 and BA.5.
This means that the immune response that the updated shot generates against the XBB mutant is likely to be similar, regardless of which specific mutant is targeted, Edwards said. .
Pfizer also presented early trial data showing that a monovalent vaccine targeting XBB variants results in an improved immune response against the XBB family.
The company provided specific timelines for distributing its latest vaccine, depending on the strain selected by the FDA.
Pfizer will be able to offer a monovalent shot targeting XBB.1.5 by July and a jab targeting XBB.1.16 by August, according to Kenna Swanson, the company’s senior principal scientist. It says.
If the FDA chooses an entirely different strain, Pfizer won’t be able to distribute a new vaccine until October, Swanson said.
Novavax did not provide a specific timeline for delivering shots targeting XBB.1.5, but noted that shots of XBB.1.16 would take eight weeks longer.
Novavax has presented preclinical data showing that monovalent vaccines targeting XBB.1.5 and XBB.1.16 induce higher immune responses against XBB subvariants than bivalent vaccines.
According to Novavax chief medical officer Dr. Filip Dubovsky, the data also demonstrate that the XBB.1.5 shot produces antibodies that block XBB.2.3 from binding and infecting human cells.
Dubovsky said test results support the use of monovalent XBB.1.5 shots in the fall.
How to use the Novavax jab protein-based technologya decades-old method to combat the virus used in routine vaccinations against hepatitis B and shingles.
The vaccine works differently than Pfizer’s and Moderna’s messenger RNA vaccines, but has the same effect of teaching the body how to fight the new coronavirus.