The Food and Drug Administration said Monday that vaccine developers do not have to do lengthy randomized controlled trials for vaccines that are adapted to protect against coronavirus variants.
The recommendations, which require small trials, more like those needed for annual flu vaccines, will significantly accelerate the review process at a time when scientists are increasingly anxious about how the variant could slow or reverse the progression against the virus.
The guidelines were part of a page of new documents the agency released Monday, including others that discuss how antibody treatments and diagnostic tests may be needed to respond to the virus variant again.
Together, it was the federal government’s most detailed recognition of the threat posed by existing variants of coronavirus vaccines, treatments and tests, and it comes weeks after FDA’s acting commissioner, Dr Janet Woodcock, said the agency ‘ develop a plan.
“The rise of virus variants raises new concerns about the performance of these products,” Dr Woodcock said in a statement on Monday. “We want the American public to know that we are using every tool in our toolbox to fight this pandemic, including the twist as the virus adjusts.”
Most of the vaccine manufacturers with authorized vaccines or candidates in late-stage trials have already announced plans to adapt their products to address the vaccine variants. The Moderna and Pfizer BioNTech vaccines use mRNA technology, which the companies say could be used within six weeks to modify existing vaccines, though testing and manufacturing will take longer.
Moderna has already started developing a new version of its vaccine that can be used as a stimulant shot against a virus variant that originated in South Africa, known as B.1.351, which increases the effectiveness of existing vaccines. lyk.
A widespread coronavirus variant first observed in Britain has also been found to have a worrying mutation that could make it more difficult to control with vaccines. This variant with the mutation was found in the United States last week.
However, the guidance does not appear to have been written on the assumption that new vaccines are imminent or not needed at all. Despite recent indications that some variants – and in particular B.1.351 – make the currently permitted vaccines less effective, the shots still provide protection and appear to significantly reduce the severity of the disease, preventing hospitalizations and death.
Asked in a newsletter on Monday afternoon about how much the variants should be distributed before updated vaccines are needed, dr. Woodcock was not given any specific criteria. “We have to anticipate this and work on having something in our back pocket before the threshold is down on us,” she said.
An updated Covid-19 vaccine could skip the month-long process of a randomized clinical trial comparing it to a placebo, the agency said. But a modified vaccine will still have to test. In trials proposed by the FDA, researchers will draw blood from a relatively small group volunteers who received the modified vaccine. Scientists will then see what percentage of samples from volunteers elicit an immune response to the variants in the laboratory, and how large the response is. The vaccines will be considered acceptable if they elicit an immune response that is relatively close to the original vaccines.
Dr Peter Marks, the largest vaccine regulator at the FDA, said in the newsletter that studies would include several hundred people and take several months.
Volunteers will also be closely monitored for side effects. The agency said the tests could be done in one age group and then exiled to other age groups.
The guidelines also encouraged the use of animal studies to support the case for modified vaccines, should immune response studies come to ambiguous conclusions.
The FDA acknowledged that many questions remained unanswered, such as what type of data would cause the need for a modified vaccine and who would make the decision. The agency also noted that scientists have not yet determined the minimum level of antibodies in the blood of a vaccinated person that would protect someone from the virus.
Some other vaccines are regularly updated in a similar way. Because the flu virus develops rapidly from one year to the next, vaccine developers have to come up with new recipes every year.
The newly adapted vaccines from Covid-19 will be granted under an amendment to the emergency authorization granted to the original vaccine, regulators said.