US slammed for rolling out Covid boosters without human trials

Health experts have warned that the United States’ decision to roll out new coronavirus boosters without clinical human testing risks damaging public trust and increasing vaccine hesitancy.

The Joe Biden administration is using the bivalent boosters, which contain the original strain of Covid-19 and the genetic code for the Omicron BA.4 and BA.5 subvariants, to vaccinate more Americans against the virus.

He bought 171 million doses of the BioNTech/Pfizer and Moderna boosters for $5 billion and fast-tracked their clearance before human trials were completed, hoping they offer better protection against dominant variants than Covid vaccines existing.

As doses began arriving at pharmacists for distribution this week, US officials said the rollout marked an “important milestone”. Going forward, people will likely only need annual boosters, much like they take an annual flu shot, they said.

But several health experts said the boosters provided only limited data from a small number of tests in mice. They said there was no evidence that they offered any better protection against infection or serious illness than the existing bites.

“Without the data and getting a human response from at least a limited number of people, you just set it up for the anti-vaxxers, anti-science [people]said Eric Topol, founder and director of the Scripps Research Translational Institute.

“There are already groups calling it the mouse vaccine. . . We already have a trust problem in this country and we don’t need to make it worse,” he said.

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Last month, the UK became the first country to approve a dual booster. But he waited until clinical data gave the green light for a shot targeting the original Covid strain and the BA.1 subvariant, which has since been replaced by BA.4/BA.5.

On Monday, Pfizer and BioNTech said the European Medicines Agency had recommended the bivalent booster BA.4/BA.5 for conditional marketing authorization based on data from the companies’ bivalent jab targeting BA.1 and preclinical data.

The two companies said the European Commission would review the EMA’s recommendation and make a final decision soon.

Experts say vaccine hesitancy is just one of many challenges facing the US recall campaign and have urged caution in prematurely declaring victory over the virus.

Two and a half years into the pandemic, there is growing public complacency towards Covid, as most people have already contracted the virus and been vaccinated. The Biden administration has also failed to secure an additional $22.4 billion in funding from Congress, which could limit its ability to replenish vaccine stocks.

“People have increased fatigue. They feel that at this stage they are mostly protected and the pandemic is largely behind them, so I think there will be less interest in these reminders,” said Paul Offit, director of Vaccine Education Center at Children’s Hospital of Philadelphia.

Offit was one of two members of a US Food and Drug Administration advisory committee to vote against asking Pfizer and Moderna to develop the bivalent vaccine without clinical data showing it worked better than the Existing Covid jab.

“What bothers me about this is are we ready to move forward with a vaccine without human data? I just think that’s a lot to ask of people,” he told the Financial Times.

Vaccination and booster rates in the United States are already lagging behind other developed countries, with two-thirds of Americans receiving two Covid vaccines and only a third of the population having received a boost. The comparable figures in France are 83% and 65%.

Health experts say the modest vaccination rate in the United States is one of the main reasons it has recorded more deaths from Covid than any other country – 1.04 million. The virus continues to kill around 350 people a day, according to the Centers for Disease Control and Prevention, and yet the number of Americans seeking recalls has fallen sharply this year.

Authorities say the threat posed by waning immunity from vaccination and the potential for a new wave of infections in the fall justify its decision to roll out bivalent boosters without clinical data.

They argue that by adapting the jab to target BA.4/BA.5, subvariants that account for over 90% of infections, as well as the original strain of Covid, it should boost immunity and do a better job. blockage. infections. The vaccine is so similar to the existing Covid vaccine and a separate bivalent vaccine targeting the BA.1 variant, which has been tested, there is no need to wait for the results of ongoing human trials, say -they.

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Some scientists agree, noting that new clinical data isn’t always needed when the flu vaccine is changed every year to target the latest strains.

Nancy Jecker, a professor at the University of Washington School of Medicine, said the risk of approving the boosters was minimal given that they are not significantly different from the original Covid jabs.

“Emergency clearance of Moderna and Pfizer boosters based on animal studies gives people the chance to minimize their Covid risk as more people congregate indoors during the fall months and winter,” Jecker said.

But Topol and Offit argued that the United States should have waited for evidence that boosters are better than existing jabs.

“I don’t think they’ve proven that this flu vaccination strategy — where we select flu strains every March for a vaccine that comes out in September — makes sense for Covid,” Offit said.

He said there was no evidence showing that the BA.4/BA.5 booster offered better protection than existing jabs. Initial clinical data of the BA.1 bivalent booster showed that it produced 1.5 to 1.75 times higher levels of anti-virus antibodies than the existing jab, which was not a clinically significant difference, Offit said.

The CDC cites a poll that suggests 72% of respondents would definitely or probably receive dual-use boosters. If uptake from the shots reaches levels similar to the annual flu vaccine – half of American adults – by early fall, CDC modeling predicts it would prevent 100,000 hospitalizations, save 9,000 lives and billions of dollars in healthcare costs.

To spur adoption, the CDC simplified its eligibility guidelines, recommending a single bivalent booster for anyone over age 12 who has ever received a Covid vaccine.

But workers on the front lines of the vaccination campaign are skeptical that the public will rush to get another shot.

“I think demand will continue to be sporadic because people who want to get vaccinated have already received the vaccine and have been reinforced,” said Rene Rodriguez, owner of Tens Pharmacy in Roseland, a small town in New Jersey.

“There are really two types of people: those who believe in the vaccine, who are usually up to date with their shots, and those who don’t.”

US slammed for rolling out Covid boosters without human trials

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