{"id":105889,"date":"2021-01-30T01:43:31","date_gmt":"2021-01-30T01:43:31","guid":{"rendered":"https:\/\/fin2me.com\/?p=105889"},"modified":"2021-01-30T01:43:31","modified_gmt":"2021-01-30T01:43:31","slug":"covid-mutations-undercut-optimism-even-as-more-vaccines-get-near","status":"publish","type":"post","link":"https:\/\/fin2me.com\/business\/covid-mutations-undercut-optimism-even-as-more-vaccines-get-near\/","title":{"rendered":"Covid Mutations Undercut Optimism Even as More Vaccines Get Near"},"content":{"rendered":"

We’re tracking the latest on the coronavirus outbreak and the global response. Sign up here for our daily newsletter on what you need to know.<\/em><\/span><\/p>\n

The world could be on the verge of having two more vaccines to fight the Covid-19 pandemic, but virus variants popping up worldwide are forcing companies that make the shots to develop boosters for a disease that could remain active for years.<\/p>\n

Vaccines made by Moderna Inc. and the Pfizer Inc.-BioNTech SE partnership are already in use. Meanwhile, new studies show that two more — from Johnson & Johnson and Novavax Inc. — pack potent punches against early forms of the virus, potentially paving the way for quick authorizations in the U.S. for J&J\u2019s vaccine and in the U.K. for Novavax\u2019s shot. That\u2019s the good news, offering the promise of ending a pandemic that\u2019s killed more than 2 million people worldwide.<\/p>\n

Now comes the bad news: Mutations that likely confer partial resistance<\/span> to vaccines and antibody treatments are now prevalent in both South Africa and Brazil, and threatening to spread worldwide. The J&J shot was found in a late-stage trial to be 72% effective in the U.S., but that fell to 57% in studies done in South Africa. Novavax\u2019s shot, 89% effective in the U.K., was only 49% effective in South Africa.<\/p>\n

Even before these results, laboratory tests on other vaccines suggested the shots would likely be less potent against the new South Africa variant. But what that meant in terms of illness in the real world was unclear. The new results offer a clear indication that vaccines won\u2019t work as well against at least one of the emerging mutations.<\/p>\n

\u201cNow we have the real world clinical consequences, and we can see that we are going to be challenged,\u201d said Anthony Fauci, the top U.S. infectious disease expert, on a conference call on Friday.<\/p>\n

State Request<\/h3>\n

The first step is to know when mutations are around. In another Friday briefing, Centers for Disease Control and Prevention Director Rochelle Walensky said the U.S. is now asking each state to send at least 750 samples a week to be sequenced to determine what mutations may be spreading.<\/p>\n

She warned that the existing U.S. system to detect different mutations is too slow for public health interventions to contain them.<\/p>\n

\u201cBy the time someone has symptoms, gets a test, has a positive result and we get the sequence, our opportunity for doing real case control and contact tracing is largely gone,\u201d Walensky said. \u201cWe should be treating every case as if it\u2019s a variant during this pandemic right now.\u201d<\/p>\n

\u2018Nimble\u2019 Response<\/h3>\n

Peter Marks, director of the U.S. Food and Drug Administration\u2019s Center for Biologics Evaluation and Research, said the agency is seeking to finalize a playbook with the industry to address mutations.<\/p>\n

If the agency feels<\/span> the virus has drifted enough to require a different sequence, it will require small trials to make sure the vaccines produce an immune response, he said. The first few 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.<\/p>\n

\u201cWe would intend to be pretty nimble with this,\u201d Marks said on an American Medical Association webinar, \u201cso we get these variants covered as quickly as possible because it is clear they can spread pretty quickly.\u201d<\/p>\n

Lab Results<\/h3>\n

Both Pfizer and Moderna — makers of the only two vaccines authorized for emergency use in the U.S. — have said their existing shots should produce enough antibodies against the South Africa mutation to make their vaccines effective.<\/p>\n

The J&J vaccine has the potential to be the next authorized in the U.S. The drug giant plans to file with the FDA for an emergency-use authorization next week. The company\u2019s top scientist said this month he expects a clearance in March.<\/p>\n

The Novavax shot, meanwhile, is likely to get its first approval in the U.K., and the company is discussing with U.S. regulators whether trial data from other countries could be part of the shot\u2019s review, Chief Executive Officer Stan Erck said. Novavax is still recruiting patients for a trial in the U.S. and Mexico, Erck said in an interview on Bloomberg Television.<\/p>\n

Spreading Quickly<\/h3>\n

The South African variant, or B.1.351, has already spread quickly across the African continent, and has been seen in at least 24 countries outside of Africa. It was found in the U.S. this week in two cases in South Carolina. Meanwhile, a highly transmissible variant hailing from the U.K., which first surfaced Dec. 29 in the U.S., has spread to 29 states in less than a month, and U.S. health officials warn it could quickly become dominant.<\/p>\n

While nations worldwide are seeking to contain the spread of the variants with travel restrictions, history suggests that\u2019s a near impossibility.<\/p>\n

The South Africa trial results are \u201cmost sobering,\u201d said Eric Topol, director of the Scripps Research Translational Institute in San Diego. \u201cWe see an unequivocal drop-off in efficacy.\u201d<\/p>\n

That means the world must now divert attention to work on a new, adjusted vaccine or booster shot that works better on the South Africa strain, while it is still ramping up injections of the first shots, according to Topol.<\/p>\n

\u201cWe are having enough struggle getting the first round of vaccines in,\u201d he said.<\/p>\n

Long Fight<\/h3>\n

The bottom line from scientists: This is a fight that could go for a long time. Vaccines that work well now may fade in the future unless booster shots are devised, something vaccine makers are already starting to work on. And it could be that Covid-19 morphs into something akin to influenza, requiring periodic booster shots over the years to keep it at bay.<\/p>\n

\u201cThe implications are really worrisome,\u201d said Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine, in an interview Thursday after the Novavax results were announced. \u201cAll the vaccine makers now have to make decisions\u201d on how to proceed.<\/p>\n

Drugmakers could start working on new, so-called bivalent vaccines, a combined shot that contains two components to stimulate the immune system against both the original strain and the South Africa variant, Hotez said. Or they could keep their existing vaccines, he said, and customize booster shots to generate antibodies against the new variants.<\/p>\n

Race to Vaccinate<\/h3>\n

So far, Pfizer, Moderna and J&J have all said they\u2019re in the process of developing booster shots or other approaches against the South Africa variant. In the meantime, it\u2019s now a race to vaccinate the U.S. and Europe before the South Africa and Brazil variants become more common or, worse yet, new mutations develop that make the virus more resistant.<\/p>\n

Fauci, in statements at the New York Press Club on Friday, said the thing that keeps him up at night is having \u201ca mutant, where it really escapes everything.\u201d<\/p>\n

He said it was \u201cconcerning that you need to stay ahead of these mutants, and essentially crush this outbreak so that there\u2019s no more replication. And when there\u2019s no more replication you\u2019re not going to have any mutations.\u201d<\/p>\n

In laboratory results reported before the new Novavax and Johnson & Johnson trial data was in, researchers from the Aaron Diamond AIDS Research Center at Columbia University found that the Pfizer and Moderna vaccines were 6.5 to 8.6 -fold less potent against the South Africa mutation.<\/p>\n

\u201cLooking at our results you cannot say this would doom the vaccine. That would be wrong. But I think it is equally wrong to say everything is rosy.\u201d said virologist David Ho, who leads the lab. \u201dWe allowed the virus to infect 100 million people already, so that is 100 million chances for mutation.\u201d<\/p>\n

\u2014 With assistance by John Tozzi, and Jeannie Baumann<\/em><\/p>\n

Source: Read Full Article<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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