Concerns over new variants of virus caused by COVID-19, US Food and Drug Administration late Thursday announced that it develop guidance to help customize manufacturers of vaccines, medicines and testing.
Existing vaccines, treatments and tests are still working well, emphasizes FDA Acting Commissioner Janet Woodcock. But now is the time to get ready for a future when they may no longer be going.
“We must prepare for all opportunities,” she said in a call to reporters.
The FDA will provide manufacturers with draft guidelines on how to customize their products as needed within the next few weeks, Woodcock said. Feedback from companies and others will help refine the lead.
Concern has increased over the past few weeks about variants of the SARS-CoV-2 virus that cause COVID-19, some of which appear more contagious.
At least one, first identified in South Africa, has made vaccinations of Novavax and AstraZeneca-Oxford vaccines less effective in that country, although they have still prevented serious illness and death.
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The Moderna and Pfizer-BioNTech vaccines also persisted when tested in Petri dishes against a new variant first seen in the UK and now spreading rapidly in the US. Moderna’s vaccination did not fare so well against the variant first seen in South Africa, although it probably still offered some protection.
PCR diagnostic tests, the gold standard for detecting infection with SARS-CoV-2, also appear to be working well, Woodcock said, although it is relatively easy to update as the virus mutations become more problematic.
With treatments, the main problem is monoclonal antibodies, which are used to prevent disease progression in high-risk patients. These drugs are extremely strictly targeted, so if the area of the virus they target changes, it can become ineffective, Woodcock said.
Companies that make monoclonal drugs are already responding by developing combinations of drugs that target multiple areas. Eli Lilly, who makes one authorized monoclonal antibody, recently announced that he hopes to add a second to ensure the treatment will remain effective despite changes in the virus.
With a vaccine, the main goal is to prevent serious illness and death, and the current shots still protect against it, said dr. Anthony Fauci, the country’s leading doctor on infectious diseases, said.
To prevent the evolution of even more dangerous variants, it is important to wear a mask, keep crowds indoors, wash hands regularly and vaccinate if possible, Fauci said during an information session in the White House earlier this week.
“Viruses cannot mutate if they do not recur,” he said. “And if you stop replicating it by vaccinating widely and not giving the virus an open playing field to keep responding to the pressure you put on it, you will not get any mutations.”
What a new vaccine might look like
While current vaccines seem to at least have an effect against the known variants, there is no doubt that the time will come when a new or modified one is needed.
All viruses mutate. The virus that causes COVID-19 has mutated rather slowly over the past year, developing only a handful of important new variants – not yet different enough to be considered scientifically as new strains.
The flu, on the other hand, develops so rapidly that new vaccines are needed every year, each addressing three or four strains.
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It is too early to know if people need a booster shot every year or two or five to prevent COVID-19 and how the vaccine may need to be adapted as the SARS-CoV-2 virus changes.
All five of the vaccines contracted by the US government to buy the “spike” protein on the surface of the SARS-CoV-2 virus. It is believed that mutations in the protein in the South African variant are behind the reduced efficacy of vaccine.
“What this tells us is that we need to be prepared,” said Dr. Jesse Goodman, a senior scholar at the O’Neill Institute for National and Global Health Law in Georgetown and former FDA chief scientist. “Because readiness is going to take time, it’s time to get started now.”
Several open-ended questions will make the process more challenging.
First, in contrast to a known disease such as influenza, COVID-19 does not make clear what levels of antibodies in the blood are sufficient to provide protection. This means that it is difficult to know whether someone is adequately protected until they become ill or not.
Researchers are now looking for so-called immune correlates of protection that can be used to determine the effectiveness of a vaccine.
And while the variants known today do not pose enough threats to vaccines, treatments or diagnostics, it will be difficult to predict which variants pose the greatest threat, Woodcock said.
Some may evade vaccines, treatments and diagnostics, but do not spread enough in the US to form a problem.
Others may spread widely, but not so much.
What is the timing?
It is not clear exactly how long it will take to make a vaccine that addresses a new variant, or more, because it has never been done.
All of the COVID-19 vaccines used in humans to date have been developed in less than a year. Designing a new version should take much less time, vaccine manufacturers said.
The technology behind Pfizer-BioNTech and Moderna’s vaccines in particular allows for rapid changes, with only a modification of the template used to make them.
In a prepared statement, Pfizer said flexibility is one of the key advantages of its mRNA platform compared to older vaccine technologies.
“This flexibility includes the ability to alter the RNA sequence in the vaccine to cover new strains of the virus,” the statement said. “Should someone emerge who is not well covered by the current vaccine, the updated vaccine can be administered as a booster.”
Pfizer CEO Albert Bourla said last week that the company “already has the foundation to respond quickly when a variant of SARS-CoV-2 evidence shows that we are escaping immunity with our vaccine,” according to the statement.
Companies and regulators have yet to work out the process that will be followed to vary the vaccines.
“We will need to generate data that gives confidence that any updated vaccine is safe and effective,” Bourla said in the statement.
There are several ways companies can modify their COVID-19 vaccines to address new variants.
First, as Moderna’s CEO mentioned, they can add a boost recording specifically aimed at a specific variant. It may require a low dose third shot for people who have already received two shots of Moderna’s vaccine.
People who have not yet been vaccinated may get a chance that addresses several variants at once, such as the annual flu shot.
The best option, Fauci said in a conversation with the New York Academy of Sciences this week, is to “develop a universal vaccine against SARS-CoV-2 to address the inevitable evolution of mutations.”
“But in the long run,” he said, “we also want to develop a universal vaccine against all coronaviruses (the family to which SARS-CoV2 belongs), as we have experienced all three separate (coronavirus) pandemics, one of which is us. still right in the middle of. ‘
Contact Karen Weintraub at [email protected].
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This article originally appeared on USA TODAY: FDA announces plan to establish guidelines to comply with COVID-19 variants