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The world may be on the verge of having two more vaccines to fight the Covid-19 pandemic, but variants of the virus emerging around the world are forcing vaccine manufacturers to develop boosters for a disease that is constantly changing and can remain active for years.
Vaccines made by Moderna Inc. and Pfizer Inc.-The BioNTech SE partnership is already in use. Meanwhile, new studies show that two more – of Johnson & Johnson and Novavax Inc. – offers potent punctures against the early forms of the virus, potentially paving the way for rapid authorizations in the United States for the J&J vaccine and in the United Kingdom for the Novavax vaccine.
Now comes the bad news: mutations that are likely to confer resistance vaccines and antibody treatments are now prevalent in South Africa and Brazil, and threaten to spread worldwide. J&J’s photo was found in a final stage trial to be 72% effective in the USA, but dropped to 57% in studies done in South Africa. The Novavax shot, 89% effective in the UK, was only 49% effective in South Africa.
Even before these results, laboratory tests on other vaccines suggested that the vaccines were likely to be less potent against the new South African variant. But what that meant in terms of disease in the real world was unclear. The new results offer a clear indication that vaccines will not work as well against at least one of the emerging mutations.
“Now we have the clinical consequences of the real world and we can see that we will be challenged,” said Anthony Fauci, the United States’ leading infectious disease specialist, in a conference call on Friday.
State Request
The first step is to know when there are mutations. In another briefing on Friday, the director of the Center for Disease Control and Prevention, Rochelle Walensky, said the United States is now asking each state to send at least 750 samples a week to be sequenced to determine which mutations may be developing. spreading out.
She warned that the existing US system for detecting different mutations is too slow for public health interventions to contain them.
“The moment someone has symptoms, gets tested, has a positive result and we get the sequence, our opportunity to do a real case control and contact tracking is gone,” said Walensky. “We must treat each case as if it were a variant during this pandemic now.”
‘Agile’ response
Peter Marks, director of the Food and Drug Administration’s Center for Biological Research and Evaluation, said the agency is trying to finalize a manual with the industry to deal with the mutations.
If the agency feel If the virus has spread enough to require a different sequence, small tests will be needed to ensure that the vaccines produce an immune response, he said. Early studies may have to go through an advisory committee, according to Marks, but the agency is looking to streamline the process as much as possible and may require less data over time.
“We intend to be very agile with this,” said Marks in a American Medical Association webinar, “so we address these variants as quickly as possible because it is clear that they can spread very quickly”.
Laboratory Results
Both Pfizer and Moderna – makers of the only two vaccines authorized for emergency use in the U.S. – said their existing vaccines should produce enough antibodies against the South African mutation to make their vaccines effective.
The J&J vaccine has the potential to be the next one authorized in the United States. The drug giant plans to enter the FDA to obtain an emergency use permit next week. The company’s chief scientist said this month that he expects a release in March.
The Novavax injection, however, is expected to get its first approval in the UK, and the company is discussing with U.S. regulators whether test data from other countries could be part of the injection analysis, said CEO Stan Erck. Novavax is still recruiting patients for a test in the United States and Mexico, Erck said in an interview with Bloomberg Television.
Spreading quickly
The South African variant, or B.1.351, already it spread rapidly across the African continent and was seen in at least 24 countries outside Africa. It was found in the United States this week in two cases in South Carolina. Meanwhile, a highly transmissible variant from the United Kingdom, which first appeared on December 29 in the United States, has spread to 29 states in less than one month, and American health officials warn that it can quickly become dominant.
While nations around the world are trying to stem the spread of travel-restricted variants, history suggests that this is next to impossible.
The test results in South Africa are “very worrying,” said Eric Topol, director of the Scripps Research Translational Institute in San Diego. “We see an unequivocal drop in effectiveness.”
This means that the world must now shift attention to work on a new adjusted vaccine or booster injection that works best with the South African strain, while injections from the first injections are still increasing, according to Topol.
“We are having a hard time getting the first round of vaccines,” he said.
Long Fight
Scientists’ conclusion: this is a struggle that can take a long time. Vaccines that work well now may disappear in the future, unless booster vaccines are planned, something that vaccine manufacturers are already starting to work on. And Covid-19 may turn into something similar to the flu, requiring periodic booster shots over the years to keep it under control.
“The implications are really worrying,” said Peter Hotez, dean of the National School of Tropical Medicine in Baylor College of Medicine, in an interview Thursday after Novavax results were announced. “All vaccine manufacturers now need to make decisions” on how to proceed.
Pharmaceuticals could start work on new vaccines called bivalents, a combined injection that contains two components to boost the immune system against the original strain and the South African variant, Hotez said. Or they can keep existing vaccines, he said, and customize booster vaccines to generate antibodies against the new variants.
Race to vaccinate
So far, Pfizer, Moderna and J&J have said they are in the process of developing booster shots or other approaches against the South Africa variant. In the meantime, it is now a race to vaccinate the US and Europe before the Africa variants from South and Brazil become more common or, even worse, new mutations develop that make the virus more resistant.
Fauci, speaking to the New York Press Club on Friday, said that what keeps him up at night is having “a mutant, where he really escapes from.”
He said it was “worrying that you needed to stay ahead of these mutants and essentially crush this outbreak so that there would be no more replication. And when there is no more replication, you will have no mutations. “
In laboratory results reported before the new Novavax and Johnson & Johnson trial data arrive, researchers at the Aaron Diamond AIDS Research Center in Columbia University found that the Pfizer and Moderna vaccines were 6.5 to 8.6 times less potent against the South African mutation.
“Looking at our results, you cannot say that it would condemn the vaccine. That would be wrong. But I think it is just as wrong to say that everything is fine ”. said virologist David Ho, who heads the lab. “We allow the virus to infect 100 million people already, so that’s a 100 million chance of mutation.”
– With the help of John Tozzi and Jeannie Baumann
(The update adds more references to the mutations in the first graph, trim in second place.)