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Concerned about new variants of the virus that causes COVID-19, the US Food and Drug Administration announced Thursday night that he develops guidelines to help vaccine, drug and test manufacturers adapt.
Existing vaccines, treatments and tests still work well, said Acting FDA Commissioner Janet Woodcock. But now is the time to prepare for a future when they may not be.
“We must prepare for all eventualities,” she said on a call to reporters.
In the coming weeks, the FDA will provide draft guidance to manufacturers on how to tailor their products as needed, Woodcock said. Feedback from companies and others will help refine these tips.
Concern has grown in recent weeks about the variants of the SARS-CoV-2 virus that cause COVID-19, some of which appear to be more infectious.
At least one, first identified in South Africa, has made the Novavax and AstraZeneca-Oxford vaccines less effective in that country, although they still prevent serious illness and death.
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Vaccines from Moderna and Pfizer-BioNTech have also held up when tested in petri dishes against a new variant first seen in the UK and now spreading rapidly across the US. still offered some protection.
Diagnostic tests using PCR, the gold standard for detecting SARS-CoV-2 infection, also appear to continue to work well, Woodcock said, although they are relatively easy to update if viral mutations become more problematic.
With treatments, the main concern is monoclonal antibodies, which are used to prevent the disease from progressing in high risk patients. These drugs are extremely targeted, so if the area of the virus they’re targeting changes, they could become ineffective, Woodcock said.
Companies that make monoclonal drugs are already responding by developing drug combinations that target multiple areas. Eli Lilly, who makes a licensed monoclonal antibody, recently announced that he hopes to add a second one to make sure the treatment continues to work, despite the changes in the virus.
With a vaccine, preventing serious illness and death is the primary goal, and current vaccines still protect against that, said Dr Anthony Fauci, the country’s leading infectious disease physician.
To avoid the evolution of even more dangerous variants, it is essential to wear a mask, avoid crowds inside, wash your hands frequently and get vaccinated when possible, Fauci said at the meeting. ‘a White House briefing earlier in the week.
“Viruses cannot mutate if they don’t replicate themselves,” he said. “And if you stop their replication by vaccinating widely and not giving the virus an open playing field to continue responding to the pressures you put on it, you will not get mutations.”
What a new vaccine might look like
Although current vaccines appear to have at least some efficacy against known variants, there is no doubt that the time will come when a new vaccine or modification will be required.
All viruses mutate. The virus that causes COVID-19 has mutated quite slowly over the past year, evolving only a handful of major new variants – not yet different enough to be scientifically considered new strains.
Influenza, on the other hand, progresses so rapidly that new vaccines are needed each year, each against three or four strains.
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It is too early to know whether people will need a booster shot every two or five years to prevent COVID-19 and how this vaccine may need to be adapted as the SARS-CoV-2 virus exchange.
The five vaccines the US government has contracted to purchase target the “spike” protein on the surface of the SARS-CoV-2 virus. It is believed that mutations of this protein in the South African variant are responsible for the reduced efficacy of the vaccine.
“What this tells us is that we need to be prepared,” said Dr Jesse Goodman, senior researcher at the O’Neill Institute for National and Global Health Law in Georgetown and former chief scientist of the FDA. “Because this preparation is going to take time, now is the time to start.”
Several open-ended questions will make the process more difficult.
First, unlike a well-known illness like the flu, it is not known with COVID-19 what levels of antibodies in the blood are sufficient to provide protection. This means that it is difficult to know whether a person is sufficiently protected until they fall ill or not.
Researchers are now looking for correlates of so-called immune protection that can be used to assess the effectiveness of a vaccine.
And while the variants known today don’t pose a sufficient threat to vaccines, treatments, or diagnostics, it will be difficult to predict which variants pose the greatest threats, Woodcock said.
Some might escape vaccines, treatments, and diagnostics, but won’t spread enough in the United States to be a problem.
Others could spread widely but not as worrying.
What’s the timing?
It is not known exactly how long it would take to make a vaccine that addresses one or more new variants, as this has never been done before.
All of the COVID-19 vaccines used in humans so far have been developed in less than a year. It should take much less time to design a new version, the vaccine makers said.
The technology behind the Pfizer-BioNTech and Moderna vaccines, in particular, allows for rapid changes, with just a modification of the model used to make it.
In a prepared statement, Pfizer said flexibility was one of the main advantages of its mRNA platform over older vaccine technologies.
“This flexibility includes the ability to modify the RNA sequence in the vaccine to cover new strains of the virus,” the statement said. “If ever a vaccine emerged that is not well covered by the current vaccine, the updated vaccine could be given as a booster.”
Pfizer CEO Albert Bourla said last week that the company “is already preparing the ground for a rapid response if a variant of SARS-CoV-2 shows evidence of evading immunity thanks to our vaccine,” according to the press release.
Companies and regulators have yet to work out the process that would be followed to vary vaccines.
“We will need to generate data that confirms that any updated vaccine is safe and effective,” Bourla said in the statement.
Companies can modify their COVID-19 vaccines in a number of ways to respond to new variants.
First off, as Moderna’s CEO mentioned, they could add a recall aimed specifically at a particular variant. This may require a third low-dose vaccine for people who had already received two injections of Moderna’s vaccine.
People who have not yet been vaccinated may be vaccinated against several variants at once, such as the annual influenza vaccine.
The best option, Fauci said in a lecture this week at the New York Academy of Sciences, would be to develop a “universal vaccine against SARS-CoV-2 to deal with the inevitable evolution of mutations.”
“But in the long game,” he said, “we would also like to develop a universal vaccine against all coronaviruses (the family to which SARS-CoV2 belongs) since we have already experienced three separate pandemics (coronavirus), one of which we are always right in the middle of. “
Contact Karen Weintraub at [email protected].
Patient health and safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial contributions.
This article originally appeared on USA TODAY: FDA Announces Intent to Draft Guidelines to Combat COVID-19 Variants
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