SHOT CLOCK — It’s been nearly a month since Pfizer and BioNTech asked the FDA to authorize the use of their Covid-19 vaccine in 12- to 15-year-olds, and still no official word from the agency. But some signs suggest the decision is imminent, including the CDC’s announcement of an emergency meeting of its vaccine advisory committee to discuss the matter on May 12. An FDA green-light would make the U.S. the second country to clear the shot for younger teens. Canada became the first on Tuesday. The companies also have sought authorization to use the vaccine for the age group in the European Union. Then there were two: Pfizer and BioNTech said Tuesday that they will file with the FDA this month for full approval of their vaccine in people 16 to 85. On Thursday, Moderna said that it, too, aims to file in May for full approval. More good news: Two studies based on extensive country-level data confirm that the Pfizer-BioNTech vaccine works as well in real life as it does in clinical trials — and provides strong protection against severe disease or death from two major variants, B.1.1.7 (first spotted in the U.K.) and B.1.351 (which emerged in South Africa). The shot was more than 95 percent effective in an analysis of data collected in Israel from late January to early April — a time when about 4.7 million people in the country had received two doses of the vaccine. It was also 95 percent effective in a study from Qatar, where 265,000 people had been fully immunized as of March 31. That study also found that the Pfizer-BioNTech shot provided 100 percent protection against severe illness or death from B.1.1.7 and B.1.351. Novavax enters the chat: The company’s Covid-19 vaccine was 51 percent effective against the B.1.351 variant in people who do not have HIV, and 43 percent effective in people who do, according to an analysis published Wednesday in the New England Journal of Medicine. The findings came from a Phase II clinical trial of more than 2,600 people in South Africa. Moderna gets a boost: A single dose of the company’s original Covid-19 vaccine and a booster shot that targets the B.1.351 variant have shown promising signs of protecting previously vaccinated people against problematic strains, the company said Wednesday. A preliminary trial run by Moderna and the National Institutes of Health examined how well the shots performed against B.1.351 and the P.1 variant first seen in Brazil, Sarah Owermohle reports. The study found that a booster dose of the variant-targeting formula was more effective than a booster of the original vaccine, but both raised antibody levels, Moderna said in a press release. The research is not yet peer-reviewed. CLOSING THE COVID THERAPY GAP — The U.S. is hitting record Covid-19 vaccination milestones, but comparatively has made little progress on treatments aimed at curbing the worst of the virus infection. That’s about to change, President Joe Biden’s chief medical adviser, Anthony Fauci, told POLITICO. “We're really putting in a considerable amount of resources in the same approach that we took to the direct acting, antiviral, targeted development of drugs that we did with HIV,” he said. “There is no reason why we can't do the same exact thing for SARS-CoV2.” Why it matters: Herd immunity is an elusive concept, especially with a virus that has spawned several concerning variants. “If we wind up getting a low level of infection in the community and it never really disappears, we're going to want to treat people as soon as they get a symptom to prevent them from being hospitalized,” said Fauci. But there are few Covid-19 therapies on the market and none to treat mild illness before someone needs clinical care. The widely available steroid dexamethasone only works against inflammation provoked by severe illness. Meanwhile, Gilead’s antiviral remdesivir is a multi-day infusion, making it impractical for people who are not hospitalized. Appili Therapeutics is slated to share interim results for a late-stage trial of a potential early coronavirus treatment — the oral flu medicine favipiravir — in about a week. The company hasn’t brought a product to market before but is relying on the antiviral’s flu benefits. Early trials in other countries haven’t yielded conclusive results. “We’re not breaking new ground here,” Appili CEO Armand Balboni told POLITICO, noting favipiravir’s long and generic history. But most research has focused on already ill patients when antivirals are typically given early to prevent severe disease. DRUGMAKERS BLAST BIDEN PLAN TO WAIVE VACCINE PATENTS — Drug lobbies PhRMA and BIO slammed an announcement by U.S. Trade Representative Katherine Tai that the White House supports waiving patent and other intellectual property protections for Covid-19 vaccines. “This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials,” PhRMA CEO Stephen Ubl said. “These are the real challenges we face that this empty promise ignores.” There’s a long road ahead for advocates who argue waiving vaccine IP protections will help expand vaccine availability in countries like South Africa and India. German Chancellor Angela Merkel said Thursday she opposes waiving vaccine intellectual property protections. A German government spokesperson said such a move would create “severe complications” for vaccine production. Moderna CEO Stéphane Bancel told investors Thursday that there “is no mRNA manufacturing capacity in the world,” and it is impossible for new entrants to hire experts, obtain necessary equipment, and establish manufacturing quickly. NO WORD FROM WHITE HOUSE ABOUT VACCINE PASSPORTS: The health tech industry is increasingly concerned that the Biden administration appears hesitant to lay out national standards for vaccine passports, POLITICO’s Darius Tahir reports. The passports are widely seen as a way to spur resumption of public life, but critics on the right have portrayed them as a government effort to force people to get Covid shots. The HHS’ IT department had begun consulting with dozens of government agencies earlier this year, but by late March, the White House had canceled internal meetings. Lobbyists have found it difficult to get information out of the administration. Many states are forging ahead with their own credentials, with some imposing strict controls on how the passports are used. But organizations like the American Medical Association warn that a lack of minimum standards could lead to technology that exposes patients’ personal information. | 
