Updated Covid booster shots designed to target new variants could be approved in just two days time, reports suggest — and be available to Americans from next week.
Four sources familiar with the matter said the Food and Drug Administration was set to green-light the shots as early as this Friday.
They would still need to get approval from the Centers for Disease Control and Prevention (CDC), but reports suggest its director Mandy Cohen could sign off on them next Wednesday, making them available.
The vaccines are expected to be offered to all age groups like the current shots are, but only 17 percent of eligible Americans have come forward for a single booster.
Moderna — one of the companies developing the new vaccine — claimed today that its shot neutralizes the ‘Pirola’ variant that has been causing concern among health experts. Pfizer also claimed its vaccine triggered enough antibodies to neutralize the variant.
But there appears to be little demand for boosters in the US.
It is not clear who will be offered the shots, but the White House previously suggested they would be made available to all age groups (stock photo)
The updated boosters are mRNA vaccines that are being made by Pfizer and Moderna. A protein-based shot is also being developed by Novavax.
The shots are all designed to target the XBB.1.5, or ‘Kraken’, variant that was dominant in the US for most of this summer.
But early test results from Moderna show their shot will also likely be effective against BA.2.86, or ‘Pirola’, which has sparked fears over a fresh wave.
Tests have already shown the shot is effective against EG.5, or ‘Eris’, which is the current dominant strain in the US.
Announcing the BA.2.86 test results today, Moderna’s head of infectious diseases Jacqueline Miller said: ‘We think this is news people will want to hear as they prepare to go out and get their fall boosters.’
The Food and Drug Administration (FDA) could approve the shots as early as this Friday, four sources told NBC News — although two added that this deadline could be pushed into early this week.
They said the agency was also looking at giving the vaccines full approval, instead of the emergency use authorization normally given to Covid shots.
An independent panel of advisors from the Centers for Disease Control and Prevention (CDC) will then meet on September 12 to determine who should receive the shots.
A sign-off from the CDC director could come as early as September 13, or next Wednesday, which would make them available nationwide, reports ABC News.
Draft CDC guidance published in June suggests the vaccines may be recommended for everyone down to children as young as two years old, but a final decision is yet to be taken.
The Biden administration suggested on August 20 that all Americans would be urged to get an updated booster vaccine.
Most Americans will be able to get the booster shots for free via their health insurance, experts say.
Vaccine uptake continues to wane in America amid anti-vaxx conspiracy theories and little sign that further shots will benefit healthy middle-aged adults.
Many experts say older adults should consider the updated Covid vaccine this winter because protection in this group is more likely to wane over time.
But they say there is little evidence that middle-aged and younger adults, among whom immunity wanes more slowly, will benefit from the shots.
A member of the FDA’s vaccine advisory committee, Dr Paul Offit, said last year that healthy young people do not need an updated booster vaccine.
He wrote in the Wall Street Journal, referring to the booster tweaked to target Omicron sub-variants: ‘The CDC found that both a third and fourth dose [of the Covid vaccine] reduced hospitalizations. But not everyone benefitted.
‘Those who did fell into three groups: The elderly, people with serious health problems and people who were immunocompromised.’
He added: ‘As the CDC launches its fall booster dose campaign, it would be wise to focus on those at risk rather than the young and healthy.’
The head of Moderna, Stephane Bancel, also admitted late last year that healthy under-50s did not need to get an annual Covid booster shot.
He told a finance meeting: ‘I think it’s going to be like the flu. If you’re a 25-year-old, do you need an annual booster every year if you’re healthy?
‘You might want to… but I think it’s going to be similar to flu where it’s going to be people at high-risk, people above 50 years of age, people with co-morbidities, people with cancer and other conditions, people with transplants.’
The above map shows the proportion of people by state who got the previous updated booster vaccine. No state went above 25 percent of coverage
About 97 percent of Americans are already thought to have a level of protection against Covid from vaccinations or previous infections.
While this may not stop someone from catching the virus, it slashes the risk that they will suffer severe disease.
The UK, which sped up its vaccine rollout after BA.2.86 was detected, is offering updated booster vaccines to all adults over 65 years old only.
When the vaccines were first rolled out, tens of millions failed to come forward to get the jab.
Uptake dipped, however, during the first wave of boosters in September 2021 — which targeted the Wuhan strain.
And the following winter — with jabs targeting the then-dominant Omicron variant plus the Wuhan virus — only 17 percent of eligible Americans came forward to get them.
Officials are expecting further poor uptake levels this year.
A CDC official said late last month: ‘Our goal, our imperative, our task, is to make sure we’re using those tools.
‘Vaccination is going to continue to be key this year because immunity wanes and because the Covid virus continues to change.’
There were concerns that the new shots would be less effective against fresh strains because these variants have slightly different sites where Covid-fighting antibodies bind to stop infections.
But many scientists have pointed out that other parts of the immune system, like T-cells, can also help fight off infections. Early tests also show that the vaccines trigger immunity against other variants.
Hospitalizations across the United States are going up, which is feared to be being driven by the EG.5 Covid variant because it is causing cases to rise
Deaths due to Covid have also risen slightly, official surveillance suggests
It comes amid mounting concern in some areas over rising Covid cases and new variants that have prompted some places to bring back face masks.
Fears spooked several colleges and businesses into bringing back mask mandates, while health officials in New York encouraged people to don face coverings over Labor Day weekend.
Concerns over the Pirola variant also saw some schools bring back face masks — even as studies showed the variant was not more transmissible than other currently circulating strains.
Data shows Covid hospitalizations across the US are ticking up, with about 15,000 people admitted to wards over the week to August 19 — up 18 percent compared to the previous seven-day period.
But this is also still well below the levels reported earlier this year when there were 44,000 admissions a week in January.
Deaths are also rising, with 616 fatalities recorded over the week to August 5, the latest available — up 20 percent from 512 in the previous week. But this is also well below levels recorded earlier this year.
Source: | This article originally belongs to Dailymail.co.uk