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Novartis AG will seek to bring its experimental Covid-19 drug to patients without waiting for results from a large clinical trial, Chief Executive Officer Vas Narasimhan said, potentially giving governments another option to battle the latest pandemic onslaught. The Swiss pharma giant aims to request an emergency-use authorization for the compound, ensovibep, with the U.S. Food and Drug Administration within the next month, Narasimhan said in an interview. A larger study to confirm promising data that emerged this week could be finished by the second half of the year, he said. (Kresge, 1/12)

The Omicron variant of the coronavirus is causing Covid-19 cases to spike, with an average of more than 747,000 new cases a day, according to the latest numbers from Johns Hopkins University. That's almost three times the average daily cases from a year ago, when the country was going through its previous peak, and it's putting an incredible strain on hospitals and emergency rooms. The good news since the last peak is that the US Food and Drug Administration authorized new antiviral pills. Both Paxlovid and molnupiravir were given emergency use authorization in late December to treat mild to moderate Covid-19. They interfere (through different pathways) with the virus' ability to replicate -- and they can be taken at home, before someone becomes seriously ill. (Kane and Kounang, 1/12)

The fact sheet for Johnson & Johnson’s Covid-19 vaccine has been revised by U.S. regulators to warn of the risk of a rare bleeding disorder. The Food and Drug Administration said in a letter to the company on Tuesday that adverse-event reports suggested an increased risk of immune thrombocytopenia, or ITP, during the 42 days following vaccination. Symptoms include bruising or excessive or unusual bleeding, according to the agency. The changes to the fact sheet include recommendations to vaccination providers about giving the J&J shot to people with existing medical conditions, including those who have a low level of platelets, a type of blood cell that helps stop bleeding. (Rutherford, 1/11)

AstraZeneca said on Thursday that preliminary data from a trial showed that its COVID-19 shot, Vaxzevria, generated an increase in antibodies against the Omicron and other variants when given as a third booster dose. The increased response, also against the Delta variant, was seen in a blood analysis of people who were previously vaccinated with either Vaxzevria or an mRNA vaccine, the drugmaker said, adding that it would submit this data to regulators worldwide given the urgent need for boosters. (Aripaka and Burger, 1/13)

European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune system and may not be feasible.  Repeat booster doses every four months could eventually weaken the immune system and tire out people, according to the European Medicines Agency. Instead, countries should leave more time between booster programs and tie them to the onset of the cold season in each hemisphere, following the blueprint set out by influenza vaccination strategies, the agency said. (Anghel, 1/11)

There’s a new kind of vaccine on the horizon — and it could help target all coronaviruses, not just Covid-19. On Tuesday, White House chief medical advisor Dr. Anthony Fauci testified to Congress about the country’s efforts to develop a pan-coronavirus vaccine, meant to combat both Covid and other similar viruses that could emerge in the coming years. The short-term applications of a vaccine that effectively tackles all forms of Covid could be significant, Fauci said: “We won’t be chasing after the next variant.” (Sauer, 1/12)

Scientists at the University of Helsinki have developed a novel nasal spray treatment that can reportedly provide protection against COVID-19 "for hours." A release from the university said the Finnish researchers had developed a molecule that has the ability to inactivate the coronavirus spike protein and offers effective short-term protection against the virus. It said that cell cultures in a petri dish and animal studies have shown that the TriSb92 molecule protects against infection for "at least eight hours even in cases of high exposure risk" and is effective immediately after its administration. (Musto, 1/12)