A COVID-19 mutation likely to confer partial resistance to the antibodies produced by vaccines is now in the US, encouraging scientists to explore new ways to combat a disease that is constantly changing and can be active for years. stay.
The South African variety has quickly spread across the African continent and has been seen in at least 24 countries outside of Africa. It was reported in South Carolina on Jan. 28 and Maryland two days later. If that just seems like a beachhead, note that a British mutation first seen in Colorado on Dec. 29 was discovered in 29 US states in less than a month. Both varieties are considered more contagious than the original species.
Recent studies released last week involving vaccines developed by Johnson & Johnson and Novavax Inc. showed that their injections are generally potent against early forms of COVID-19. But results from studies conducted in South Africa told a less impressive story. The J&J intake was found to be 72% effective in the US, but that dropped to 57% in South Africa. Novavax’s shot, 89% effective in the UK, was only 49% effective in South Africa.
The results are “sobering,” said Eric Topol, director of the Scripps Research Translational Institute in San Diego. “We are seeing an unequivocal decrease in efficacy.”
That means vaccine makers must now divert attention to work on booster shots or a new, modified vaccine that can work better against the South African mutation, known scientifically as B.1.351, even as the world’s injections of the first shots. put into use, he said.
“We are fed up with the fight to get the first round of vaccines,” Topol said.
Lab tests
Before the results of J&J and Novavax were made public, lab tests looking at the number of antibodies induced by vaccines from Pfizer Inc. and Moderna Inc. which are already in use, that while they may be less powerful against the South African variety, they still had plenty of them. punch to keep it off.
But what that meant in terms of real-world illness was unclear. The latest results provide a more precise indication, Anthony Fauci, America’s top infectious disease expert, said in a conference call Friday.
“It’s really a wake-up call for us to be nimble and to adapt as this virus will certainly continue to evolve and mutate,” he said. “Now we have the clinical implications in the real world, and we can see that we will be challenged.”
In statements to the New York Press Club on Friday, Fauci said it was “ worrying that you have to stay ahead of these mutants and essentially crush this outbreak so that there is no more replication. And when there is no more replication, you have no mutations. “
In lab results reported before the new Novavax and J&J research data came in, scientists at Columbia University’s Aaron Diamond AIDS Research Center found that the Pfizer and Moderna vaccines were 6.5 to 8.6 times less potent against the South African mutation.
100 million opportunities
“If you look at our results, you cannot say that this would doom the vaccine. That would be wrong, ”said David Ho, who runs the lab. “But I think it’s equally wrong to say that everything is rosy.”
The world has “allowed the virus to infect 100 million people already,” he said. “So that’s 100 million chances of mutation.”
The late-phase studies reported by J&J and Novavax last week could potentially pave the way for authorization for use. J & J’s vaccine offers users a one-shot regimen, unlike the two-dose versions approved for Pfizer and Moderna. The drug giant plans to file an application with the U.S. Food and Drug Administration for an emergency use license this week, company officials said. J & J’s top scientist said this month that he expects a cleanup in March.
The Novavax recording, meanwhile, is likely to receive its first approval in the UK, and the company is discussing with US regulators whether trial data from other countries could be part of the assessment of the recording, Chief Executive Officer Stan Erck said. Novavax is still recruiting patients for trial in the US and Mexico, Erck said in an interview on Bloomberg Television.
Still, Pfizer, Moderna and J&J have all said they are starting to develop booster shots or other approaches to support their vaccines. It remains unclear how long the injections will immunize people against COVID-19, and new mutations may require changes in their composition.
First step
For the US, the first important step is to know when there are mutations. In another briefing on Friday, Rochelle Walensky, director of Centers for Disease Control and Prevention, said the US has now asked each state to send at least 750 samples per week to be sequenced to determine which variants may be here and how widely they can spread.
She warned that the existing US system to detect various mutations is too slow to prevent public health interventions.
“By the time someone has symptoms, gets a test, has a positive result, and we get the sequence, our chances of doing real case checking and contact tracking are largely gone,” Walensky said. “We should treat every case during this pandemic as if it were a variant.”
While countries around the world, including the US, try to stem the spread of the travel-restricted variants, history suggests this is nearly impossible.
Industry playbook
Meanwhile, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency wants to finalize a roadmap with the industry to address mutations.
If the agency believes the virus has drifted enough to require a different sequence, small tests are needed to make sure the vaccines are producing an immune response, he said. The first few investigations may need to go through an advisory committee, according to Marks, but the agency tries to streamline the process as much as possible and may need less data over time.
“We plan to be pretty nimble with this,” Marks said at a webinar for the American Medical Association, “so that we can treat these variants as soon as possible, because it is clear that they can spread quite quickly.”
Long fight
The bottom line from scientists: This is a fight that can last a long time.
Vaccines that work well now may fade in the future unless strong booster shots are devised. And it could be that COVID-19 turns into something similar to the flu, requiring periodic booster shots over the years to keep it at bay.
“The implications are really concerning,” said Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine, in an interview Thursday after Novavax’s results were announced. “All vaccine manufacturers now have to make decisions” about how to proceed.
Meanwhile, it is now a race to vaccinate the US and Europe before the South African variant becomes more common or, worse, new mutations emerge that make the virus more resistant.
In his comments in the New York Press Club, Fauci was asked what keeps him up at night. His answer: “A mutant, where he really escapes everything.”
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