CDC OKAYS PFIZER VACCINE FOR TEENS — The CDC’s vaccine advisory committee on Wednesday endorsed Pfizer’s Covid-19 shot for 12- to-15-year-olds. CDC Director Rochelle Walensky officially adopted the recommendation hours later. Federal health officials have said that vaccinating teens is key to ending the pandemic, and will make it safer for them to return to school in the fall. President Joe Biden said 15,000 pharmacies are ready to immunize the youngsters, along with school-based clinics, family health centers and pediatricians' offices. All in one go: At the meeting, CDC staff announced that Covid-19 vaccines can now be given at the same time as other shots, after previously recommending a two-week waiting period before or after a Covid shot. That could help teens getting Covid vaccines catch up on any other shots they missed during the pandemic. The advisory panel recommended that children (or adults) receive any vaccine they may be missing along with their Covid-19 shot, in line with recommendations from the American Academy of Pediatrics. "[The advisory committee is] trying to weigh two competing facts," Paul Offit, a pediatrician at the Children's Hospital of Philadelphia, told POLITICO. On the one hand, there's no data on co-administering Covid-19 vaccines with other vaccines; but on the other, scientists know that missed vaccinations lead to spikes in other infectious diseases, like measles. Early on in the pandemic, measles vaccinations in the U.S. slipped below their usual level as fewer people ventured to doctors' offices for routine visits. "Whenever you put limitations on windows, you create opportunities for missed vaccination," said Eleanor Menzin, a pediatrician at Longwood Pediatrics in Boston and professor at Harvard Medical School. Best practices for pediatrics are to give any overdue vaccinations to children whenever they come into the doctor's office, Menzin says. Because children or young teens generally need more vaccinations than adults, including HPV and meningitis, it's easier to administer multiple shots at once. MORE J&J-LINKED CLOTTING CASES REPORTED — The CDC confirmed at Wednesday’s meeting that it has identified 28 cases of a rare blood clotting disorder among roughly 8.73 million people who received the Johnson & Johnson Covid-19 vaccine, nearly double the number previously known. The cases predominantly occurred in women, though six were reported in men. Those affected ranged in age from 18 to 59, slightly older than previously found. But most cases have occurred in people ages 30 to 49, with reporting rates for the syndrome higher for women in all age categories. Available evidence suggests a "plausible causal association" with the J&J vaccine, but still no definitive link, said Tom Shimabukuro of the CDC's Covid-19 vaccine task force. Lingering concerns: One member of the advisory panel said that amending its warning label to increase the age range of potentially affected populations might be warranted. But Arthur Caplan, a bioethics professor at NYU, told POLITICO he doesn’t think the new data justifies such a change. “Every time you expand the warning label, you better mean it,” he said. Leana Wen, an emergency physician and public health professor at George Washington University, told POLITICO that the group that appears most at risk for the clotting syndrome — women ages 30 to 49 — should have the option of getting the Pfizer or Moderna shots first. If they still prefer J&J, she said, “absolutely that is a reasonable choice, but they need to be given information to make that decision, as well as the option for other vaccines.” That nuance should be more easily communicated now that Covid vaccine administration is shifting from mass sites to pharmacies and doctor’s offices. EMAILS SHED LIGHT ON LAST SUMMER'S CONVALESCENT PLASMA DEBATE — Newly obtained emails reveal intense disagreement among federal health officials over convalescent plasma — and the scramble to organize their messaging around the treatment — in the days leading up to FDA’s controversial decision to authorize its use against the coronavirus last summer, POLITICO's Sarah Owermohle and Adam Cancryn report. The emails , obtained through a Freedom of Information Act request, shed new light on the interagency battle that forced FDA to hold off on its authorization for days, frustrating top officials and contributing to public confusion around the treatment's effectiveness. The FDA’s authorization in late August came shortly after then-President Donald Trump attacked the agency for moving too slowly to clear the treatment, stoking further concerns over politics driving decision-making at the nation’s top science agencies during the pandemic. The back-and-forth between NIH and FDA officials leading up to authorization of the treatment to some extent played out in public last summer. But the new batch of emails reviewed by POLITICO shows how top officials, including some still leading the government’s Covid response, struggled to navigate differences over plasma’s usefulness amid intense White House pressure to declare it a breakthrough treatment. Several have since taken lead roles in the Biden administration’s effort to restore public trust in the pandemic response — including NIH Director Francis Collins and Anthony Fauci, the agency’s top infectious-disease specialist, who had aired concerns in the weeks before authorization that the evidence on plasma’s effectiveness was too thin. That didn’t sit well with FDA’s top vaccine official, Peter Marks, who in emails complained that NIH scientists should not comment on regulatory reviews that are squarely within FDA’s authority. REPUBLICANS BLAST VACCINE IP WAIVER — U.S. Trade Representative Katherine Tai faced intense Republican criticism on Wednesday over the administration's support of a WTO proposal that would temporarily lift intellectual property protections for Covid-19 vaccines, POLITICO’s Doug Palmer and Steven Overly report. Nearly every Republican on the Senate Finance Committee said they opposed the move, which they argue could set off a scramble for vaccine ingredients and complicate manufacturing efforts in the U.S. Finance Committee Chair Ron Wyden (D-Ore.) said he wants “a balanced vaccine IP waiver” that enables the timely and safe production of vaccines and the distribution of those shots to people in need. He also told Tai to tackle other health care trade barriers. |