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FDA addresses coronavirus variants in updated guidance for medical developers

FOX News

Dr. Tom Inglesby, Johns Hopkins Center for Health Security director, tells'Fox News Sunday' he is'concerned' about virus mutations. The Food and Drug Administration issued new guidance on Monday amid the emergence of new coronavirus variants for medical product developers. The regulatory agency said it is "committed to identifying efficient ways to modify medical products" that either are in the works or have already been authorized for emergency use to address the variants. "We know the country is eager to return to a new normal and the emergency of the virus variants raises new concerns about the performance of these products," Dr. Jane Woodcock, acting FDA commissioner, said in a news release. "By issuing these guidances, we want the American public to know what that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines."

The South African covid-19 variant is proving to be a vaccine challenge

MIT Technology Review

The news: US company Novavax has today announced that its covid-19 vaccine was found to be 89% effective in final-stage clinical trials in the UK. It discovered the vaccine protects people with the UK covid-19 variant, known as B.1.1.7, The details: The Phase 3 trials enrolled more than 15,000 people aged between 18 and 84. The Novavax vaccine, which requires two doses, was 86% effective against the UK variant, but in the South African wing of the trial, where most people had the South African covid-19 variant, the vaccine was just 50% effective (similar to the level of protection conferred by most flu vaccines.) The UK has bought 60 million doses of the vaccine which will be produced locally.

$1.6 billion going toward coronavirus testing, sequencing, supplies, fed gov announces

Boston Herald

An investment of $1.6 billion dollars in federal funding will improve coronavirus testing in schools and vulnerable communities, genomic sequencing to better identify variants, and testing materials that are still in short supply, White House officials announced. The federal government will invest $1.6 billion in three key areas around testing: The largest portion of funding, $650 million, will help create regional vaccine coordinating centers that will partner with labs to leverage testing capacity and help to reopen schools and test people in congregate living facilities, said Carole Johnson, White House COVID Response Team testing coordinator. "These are places that typically don't have the resources or the bandwidth to build partnerships with academic or commercial testing labs, and that's where the government can be a facilitator," Johnson said in a Wednesday briefing. Nearly $200 million will help to expand genomic sequencing, which is the process that identifies coronavirus variants circulating in the country and can be used to track and stop the mutations. The Centers for Disease Control and Prevention will be able to sequence 25,000 samples a week with the funding, a threefold increase, according to Johnson.

WHO group recommends use of AstraZeneca vaccine

Boston Herald

Independent experts advising the World Health Organization about immunization on Wednesday recommended the use of AstraZeneca's vaccine even in countries that turned up worrying coronavirus variants in their populations. The WHO experts' advice is used by health care officials worldwide, but doesn't amount to a green light for the United Nations and its partners to ship the vaccine to countries that have signed up to receive the shots through a global initiative. That approval could come after separate WHO group meetings on Friday and Monday to assess whether an emergency-use listing for the AstraZeneca vaccine is warranted. The AstraZeneca vaccine is important because it forms the bulk of the stockpile acquired so far by the U.N.-backed effort known as COVAX, which aims to deploy coronavirus vaccines to people globally. COVAX plans to start shipping hundreds of millions of doses of the vaccine worldwide later this month, but that is contingent on WHO approval for the shot, vaccine stocks and countries' readiness to receive it.

BioNTech CEO confident vaccine will work on UK variant

Boston Herald

German pharmaceutical company BioNTech is confident that its coronavirus vaccine works against the new UK variant, but further studies are needed to be completely sure, its chief executive said Tuesday. The variant, detected mainly in London and the southeast of England in recent weeks, has sparked concern worldwide because of signs that it may spread more easily. While there is no indication it causes more serious illness, numerous countries in Europe and beyond have restricted travel from the UK as a result. "We don't know at the moment if our vaccine is also able to provide protection against this new variant," CEO Ugur Sahin told a news conference the day after the vaccine was approved for use in the European Union. "But scientifically, it is highly likely that the immune response by this vaccine also can deal with the new virus variants."