Covid-19 roundup: FDA all but rejects changes to authorized vaccine plans; Israel approves Moderna's vaccine as countries race to get shots in arms
Just one day after OWS chief Moncef Slaoui said he had pushed the FDA to consider halving Moderna’s Covid-19 vaccine doses to counteract distribution lags, the agency poured cold water on the notion Monday night, as well as on other potential alternatives.
The idea of changing authorized vaccine doses or schedules for any Covid-19 vaccine is “premature” and not supported by available data, FDA chief Stephen Hahn and CBER director Peter Marks said in a joint statement. Hahn said regulators have been following the recent debates and news reports about trying to get more people vaccinated more quickly, but noted altering any authorized procedure amounts to a “significant risk” for public health.
While the pair said the discussions raised reasonable questions, none of the proposals are currently backed by the available evidence. In addition to cutting Moderna’s vaccine dose in half, potential ideas included extending the time between doses, reducing the number of doses and mixing and matching different vaccines.
Regarding the half-dose or single-dose vaccine plans, Hahn and Marks pointed to the lack of understanding the “depth and duration” of protection that might provide.
“There is some indication that the depth of the immune response is associated with the duration of protection provided,” they said. “If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks.”
When it comes to delaying the second doses of vaccines, the duo appeared to refer to reports claiming that Pfizer and BioNTech’s vaccine may provide some protection after just one shot. But they noted that within Pfizer’s late-stage trial, only a small percentage of volunteers — about 2% — did not receive the second dose at the prescribed three-week interval, and those individuals were only followed for a short period of time. In Moderna’s Phase III study, roughly 8% of participants got their second shot later than the four-week mark.
“We cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies,” the statement reads.
The FDA’s statement comes after Slaoui told Face the Nation on Sunday that he would be in favor of slashing the Moderna vaccine dose from 100 μg to 50 μg in order to allow more people access to the jabs. He had cited data from the biotech’s clinical trials that showed adults aged 18 to 55 who received the lower doses showed an “identical immune response” compared to the higher level.
Complicating matters further was the UK’s decision to delay the second dose of the Pfizer/BioNTech and AstraZeneca vaccines — the latter of which is not yet authorized in the US.
Vaccine rollout has proved challenging and is lagging behind initial federal projections, with only 4.2 million Americans receiving their first shots as of Saturday, per the CDC. Health officials had aimed for 20 million doses administered by the end of 2020, but the CDC’s numbers are likely higher due to reporting lags. — Max Gelman
Israel approves Moderna’s vaccine as countries race to get shots in arms
Israel has become the third country to authorize Moderna’s mRNA Covid-19 vaccine, behind the US and Canada.
The country’s Ministry of Health authorized the vaccine on Monday, based on a rolling submission of data including an analysis from a pivotal Phase III study announced on Nov. 30, according to Moderna. Israel’s MOH has secured 6 million doses, with the first deliveries expected shortly.
“Today’s authorization is a landmark moment in our company’s history and in the global fight against COVID-19,” Moderna CEO Stéphane Bancel said in a statement. “ We hope to continue to see authorizations in additional markets in the coming days, weeks and months,” he added later.
Moderna’s vaccine candidate is currently under regulatory review in the EU, Singapore, Switzerland and the UK. The EMA’s committee for human medicines (CHMP) met on Monday to discuss the vaccine, but the agency tweeted that the discussion has not concluded and will continue on Wednesday.
EMA's committee for human medicines (CHMP) discussion on COVID-19 vaccine Moderna has not concluded today. It will continue on Wednesday 6th January 2021. No further communication will be issued today by EMA.
— EU Medicines Agency (@EMA_News) January 4, 2021
Back in December, the European Commission exercised an option to purchase 80 million additional doses of Moderna’s shot, bringing its commitment to 160 million doses. The US government struck a deal about a week prior for an extra 100 million doses, doubling the amount of vaccine they’ll receive from Moderna next year.
Moderna has said their jab likely protects against a new variant of the coronavirus detected in the UK and in Colorado, which scientists believe is more contagious. The company is running additional tests to confirm. — Nicole DeFeudis
For a look at all Endpoints News coronavirus stories, check out our special news channel.