Covid Mutations undermined optimism, even as more vaccines approach

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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

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