A COVID-19 mutation that is likely to give partial resistance to vaccine-producing antibodies is now in the United States, prompting scientists to explore new ways to fight a constantly changing disease that could remain active for years.
The South African variant has already spread rapidly on the African continent and has been seen in at least 24 countries outside Africa. It was reported in South Carolina on January 28 and in Maryland two days later. If this only looks like a beachhead, keep in mind that a British mutation first seen in Colorado on December 29 was detected in 29 US states in less than a month. Both variants are considered more contagious than the original strain.
Subsequent studies launched last week with vaccines developed by Johnson & Johnson and Novavax Inc. have shown that their shots are generally strong against early forms of COVID-19. But the results of studies in South Africa have told a less impressive story. The J&J shot was found to be 72% effective in the US, but it dropped to 57% in South Africa. Novavax’s image, with 89% effect in the UK, was only 49% effective in South Africa.
The results are “worrying,” said Eric Topol, director of the Scripps Research Translational Institute in San Diego. “We are seeing an unequivocal decrease in effectiveness.”
This means that vaccine manufacturers must now turn their attention to working on either booster shots or a new, adjusted vaccine that can work better against the South African mutation, scientifically known as B. 1,351, even as the world accelerates injections of the first photographs put into use, he said.
“We have enough struggle to get the first round of vaccines,” Topol said.
Laboratory tests
Before the results of J&J and Novavax are made public, laboratory tests that look at the number of vaccine-induced antibodies from Pfizer Inc. and Moderna Inc. already in use suggests that, although they may be less strong against the South African variant, they still had enough fist to stop it.
But what this meant in terms of disease in the real world was unclear. The latest results provide a more accurate indication, Anthony Fauci, America’s leading infectious disease expert, said in a conference call on Friday.
“It’s really a wake-up call for us to be agile and able to adapt, because this virus will continue for some to evolve and move,” he said. “Now we have the real-world clinical consequences and we can see that we will be challenged.”
In a statement to the New York Press Club on Friday, Fauci said it was “worrying that you have to stay ahead of these mutants and, in essence, crush this outbreak so that there is no replication.” And when there is no replication, you will not have mutations. ”
In laboratory results reported before new data from the Novavax and J&J studies appeared, scientists at the Aaron Diamond AIDS Research Center at Columbia University found that Pfizer and Moderna vaccines were 6.5 to 8.6 times less strong against the South African mutation.
100 million chances
“Looking at our results, you cannot say that this would condemn the vaccine. It would be wrong, “said David Ho, who runs the lab. “But I think it’s just as wrong to say everything is pink.”
The world has “allowed the virus to infect 100 million people already,” he said. “So there’s a 100 million chance of mutation.”
The late studies reported last week by J&J and Novavax could pave the way for them to be authorized for use. The J&J vaccine offers users a unique shooting regime, unlike the two-dose versions authorized for Pfizer and Moderna. The drug giant plans to file an emergency authorization with the US Food and Drug Administration this week, company officials said. J & J’s top scientist said this month that he expects to be licensed in March.
Meanwhile, the Novavax shooting will receive its first approval in the UK, and the company is discussing with US regulators whether data from studies in other countries could be part of the shooting review, said executive director Stan Erck. Novavax is still recruiting patients for a trial in the United States and Mexico, Erck said in an interview with Bloomberg Television.
However, Pfizer, Moderna and J&J have all said they are starting to work on developing booster shots or other approaches to strengthen their vaccines. It remains unclear how long the photos will immunize people against COVID-19, and new mutations may require changes in their structure.
First step
For the US, the first important step is to know when there are mutations. In another briefing Friday, Director of Centers for Disease Control and Prevention Rochelle Walensky said the United States has asked each state to send at least 750 samples a week to be sequenced to determine what variants may be here and how many wide can spread.
She warned that the existing American system for detecting various mutations is too slow for public health interventions to contain.
“Until someone has symptoms, gets a test, has a positive result, and we get the sequence, our opportunity to do real case control and follow-up contacts has largely disappeared,” Walensky said. “We should treat each case as if it were a variant during this pandemic right now.”
While nations around the world, including the United States, are trying to limit the spread of travel-restricted variants, history suggests that it is almost impossible.
The playing card of the industry
Meanwhile, Peter Marks, director of the FDA’s Center for Biological Assessment and Research, said the agency is trying to finalize a manual with the industry to address the changes.
If the agency believes the virus has derived enough to require a different sequence, it will require small studies to ensure vaccines produce an immune response, he said. According to Marks, the first studies may go through an advisory committee, but the agency is trying to streamline the process as much as possible and may require less data over time.
“We aim to be quite agile in this,” Marks said at an American Medical Association webinar, “so we’re getting these covered options as soon as possible, because it’s clear that they can spread pretty quickly.”
Long fight
Scientists conclude: this is a fight that could take a long time.
Vaccines that work well now may fade in the future unless strong booster shots are designed. And COVID-19 may turn into something like the flu, requiring regular booster strokes over the years to keep it at bay.
“The implications are really worrying,” Peter Hotez, dean of the Baylor College of National School of Tropical Medicine, said in an interview Thursday after the Novavax results were announced. “All vaccine manufacturers must now make decisions” on how to proceed.
Meanwhile, there is now a race for vaccination in the US and Europe before the South African variant becomes more common or, worse, new mutations develop that make the virus more resistant.
In his comments to the New York Press Club, Fauci was asked what keeps him awake at night. His answer: “A mutant, where he really gets rid of everything.”
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