FDA debates new vaccines | Covid funding in limbo | Myocarditis higher after infection

VIEW IN BROWSER | SUBSCRIBE Fri, Apr 08, 2022 EDITOR'S NOTE Think a friend or colleague should be getting this newsletter? Share this link with them to sign up.   It's been well over a year since the FDA authorized the first Covid vaccine, and the shots are still targeting the original Wuhan strain despite the fact that the virus has evolved dramatically since then, undermining protection against infection.   The FDA's advisory committee met this week to debate whether the U.S. needs to change the vaccines to target different Covid variants, but the timeline to make a decision is tight. Dr. Peter Marks, a top FDA official, said the U.S. needs to decide by June to have the shots ready ahead of a possible fall wave of infection.  Pfizer and Moderna are both testing omicron-based vaccines, but federal officials said they are not coordinating their studies, and it's not clear if they are working on the most effective formula for the fall   FDA committee members told CNBC that the vaccine makers are playing too large a role in deciding what will go into shots. They want the FDA to take the lead in selecting the virus strain that goes into the vaccines, similar to the way a new flu shot is selected every year.    Committee members also questioned whether an update is really needed, noting that the current vaccines still provide strong protection against severe illness.    It's also not clear if the U.S. will even have the money to purchase new vaccines. The Senate reached a $10 billion Covid funding deal this week, but Congress went on vacation without passing the legislation.   In other news, the risk of myocarditis is much higher after Covid infection than vaccination with Pfizer or Moderna's shots, according to the CDC's first large study on the issue. The findings might help assuage the concerns of some parents about getting their children vaccinated. Feel free to send any tips, suggestions, story ideas and data to me at spencer.kimball@nbcuni.com. Spencer Kimball | Health Reporter @spencekimball Spencer Kimball | Health Reporter @spencekimball Scientists divided on need for 4th Covid shot after FDA quietly approved another round of boosters Leading U.S. scientists and physicians worry that the FDA and CDC are moving too fast in approving a fourth round of Covid shots, with little public debate that gives the vaccine makers too big a role in setting the pace with which the doses are distributed across the nation.   The top U.S. public health agencies last week endorsed a fourth Covid shot for older adults without holding public meetings, drawing criticism from leading vaccine experts who believe federal health officials haven't provided enough transparency about the reasons for the decision. - Spencer Kimball U.S. has until June to decide whether we need new Covid shots for this fall, FDA official says Dr. Peter Marks, who leads the Food and Drug Administration office responsible for vaccine safety and efficacy, told the agency's advisory committee Wednesday that a decision needs to be made by June on selecting a new strain for the vaccines in order to have them ready in the fall.   However, there are a lot of uncertainties that make updating the shots difficult. Trevor Bedford, a virologist at the Fred Hutchinson Cancer Research Center, said Covid has mutated two to 10 times faster than the flu. Bedford said it's difficult to predict whether another heavily mutated variant will come along that upends the pandemic response as omicron did over the winter.   "We really don't know whether these wildly divergent viruses will be a common feature, or a rare feature of endemic SARS-CoV-2 evolution," Bedford said. - Spencer Kimball Myocarditis risk higher after Covid infection than Pfizer or Moderna vaccination, CDC finds People infected with Covid-19 face a higher risk of myocarditis and other inflammatory heart conditions than those vaccinated against the disease, according to a large study published by the Centers for Disease Control and Prevention.   Pfizer and Moderna's vaccines have been associated with an elevated risk of myocarditis and pericarditis after the second dose, particularly among boys ages 12- to 17-years-old. However, even in this group the risk of myocarditis and pericarditis was higher after Covid infection than after vaccination, according to the CDC. - Spencer Kimball Congress goes on vacation without passing $10 billion Covid funding deal Senate Republicans and Democrats reached a deal Monday on $10 billion in additional Covid funding to buy therapeutics and vaccines and maintain the nation's testing capacity if another Covid wave hits the U.S. However, Congress left Washington for a two-week vacation without passing the additional funding, which is less than half the $22.5 billion that President Joe Biden first requested. It's unclear when lawmakers will vote on the deal.   The White House has warned of dire cuts to testing and treatments if more money doesn't come through. - Spencer Kimball High immunity in U.S. provides some protection against omicron BA.2, CDC director says CDC Director Rochelle Walensky on Tuesday said there is enough immunity in the U.S. population to provide some protection against the more contagious omicron  subvariant, which could help stave off another Covid wave that slams hospitals. An estimated 95% of the U.S. population ages 16 and older had developed antibodies against the virus either through vaccination or infection as of December, according to a CDC survey of blood donor samples.   However, simply having antibodies against the virus does not necessarily stop an infection. But people who are vaccinated, boosted and those who recovered from a prior infection do have high levels of protection against hospitalization from BA.2, according to a study published by scientists in Qatar.   - Spencer Kimball UK has detected a new Covid variant. Here's what we know so far about omicron XE A new omicron subvariant has been detected in the U.K. as the country faces a renewed surge in Covid-19 hospitalizations. The XE variant, as it is known, has so far been detected in 637 patients nationwide, according to the latest statistics from the U.K. Health Security Agency.  UKHSA data shows XE has a growth rate of 9.8% above that of BA.2, while the World Health Organization has so far put that figure at 10%. - Karen Gilchrist, Singapore JOIN US REGISTER CONTRIBUTORS Bertha Coombs @berthacoombs Meg Tirrell @megtirrell Bertha Coombs @berthacoombs Meg Tirrell @megtirrell Unsubscribe Manage Newsletters Terms of Service Join the CNBC Panel   Digital Products Feedback Privacy Policy CNBC Events   © 2022 CNBC LLC. All rights reserved. A property of NBCUniversal. 900 Sylvan Avenue, Englewood Cliffs, NJ 07632 Data is a real-time snapshot *Data is delayed at least 15 minutes. Global Business and Financial News, Stock Quotes and Market Data and Analysis. Data also provided by THOMSON REUTERS