FDA: MODERNA, PFIZER KIDS' VACCINES SAFE AND EFFECTIVE — Two Covid-19 vaccine options for babies and toddlers are safe and effective, FDA reviewers said in briefing documents posted online over the weekend, Lauren reports. The announcement sets the stage for regulators to potentially authorize the shots for emergency use later this week. The three-dose Pfizer-BioNTech vaccine for kids ages 6 months through 4 years will likely benefit this age group, the FDA said, noting higher hospitalization and death rates among the youngest children in the U.S. compared with those 5 and older. Moderna's two-dose Covid-19 vaccine regimen for children is generally safe and effective for children ages 6 months to 17 years, the FDA said in a separate briefing document on Friday. The documents will form the basis of the FDA's independent vaccine advisers' review at meetings on Tuesday and Wednesday when they'll vote on whether to recommend that the agency endorse EUAs for the age groups. The FDA analyzed both vaccines' ability to induce neutralizing antibody responses in kids that were comparable with those of young adults, a concept known as immunobridging. Real-world efficacy against the Omicron variant in the 6-month-to-5-year-old age group for Moderna's vaccine ranged from 36 to 51 percent, but efficacy estimates for all age groups were "generally consistent" with rates seen in observational studies of adults during the same variant waves, the FDA said. No new safety signals were detected in the companies' clinical trials, though they were unlikely large enough to detect the rarest side effects, the FDA said. STATE JUSTICES TAKE CENTER STAGE IN ABORTION FIGHT — The right to abortion in some states could come down to state supreme court justices, POLITICO's Megan Messerly reports. If the Supreme Court overturns Roe v. Wade in the coming weeks, state courts are likely to be flooded with new litigation that could require them to rule on abortion access, putting the spotlight on down-ballot races that voters usually pay little attention to in the midterms. Judges are supposed to be impartial arbiters of the law, but many judicial candidates are using not-so-subtle clues — such as saying they oppose "the overreach of government" or support "fairness, equality and respect" — to signal how they might rule. Eight states require judges to run with their party affiliation next to their name on the ballot. Unsurprisingly, organizations on both sides of the abortion debate are planning to spend big to tip the scales in their favor. While most of the spending won't happen until the fall, races in Ohio, Michigan and North Carolina — where abortion litigation is almost certain — are already garnering significant attention because partisan control is at stake. BIPARTISAN GUN SAFETY DEAL COMES INTO FOCUS — A day after thousands of protesters convened in Washington, D.C., demanding tighter gun safety laws, senators said on Sunday they had struck a bipartisan deal on gun safety, POLITICO's Burgess Everett and Marianne Levine report. The framework includes extra scrutiny for under-21 gun buyers, grants to states to introduce red-flag laws and new spending on mental health and school security. The group of 20 senators — 10 Republicans and 10 Democrats — who came out in support of the law indicated it has a chance of passing the Senate. President Joe Biden urged both chambers to pass the legislation quickly. Sens. Chris Murphy (D-Conn.), John Cornyn (R-Texas), Kyrsten Sinema (D-Ariz.) and Thom Tillis (R-N.C.) are the lead negotiators on the proposal. Senate Majority Leader Chuck Schumer endorsed it; Minority Leader Mitch McConnell said the deal showed the value of cooperation but stopped short of backing it.
| 
Comments
Post a Comment