PFIZER SAYS ANTIVIRAL SHARPLY REDUCES SEVERE COVID — The company’s experimental antiviral pill reduces hospitalization and death from the coronavirus as much as 89 percent, the company said early Friday — setting it up as a key treatment to curb Covid-19 before it gets severe. Pfizer's new data on the drug, Paxlovid, came from an interim analysis of its Phase II/III trial among more than 770 high-risk adults with Covid-19 who were treated within three days of the onset of symptoms or given a placebo. The drug was slightly less effective when given up to 5 days after patients developed symptoms, the company said. But the data is positive enough that Pfizer is halting trials after this interim analysis and filing with the Food and Drug Administration ASAP, it said in a statement. “Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” Pfizer CEO Albert Bourla said. Paxlovid could prove a critical part of early Covid-19 treatment to curb hospitalization and severe illness in part because pills are easier to manufacture and distribute than available therapies usually administered by providers, like monoclonal antibodies. Its interim analysis included results from more than 1,200 people randomly distributed in treatment and placebo arms. Six people in the Paxlovid arm were hospitalized and none died; 41 people in the placebo arm were hospitalized and 10 died. Big week for Pfizer: ICYMI (though we’re sure you didn’t), the CDC signed off on recommendations Tuesday for vaccinating kids ages 5 to 11 against Covid with Pfizer’s product. EMERGENT, U.S. END STANDBY EMERGENCY VACCINE MANUFACTURING DEAL — Emergent BioSolutions and the Biomedical Advanced Research and Development Authority “mutually agreed” to end an agreement under which the manufacturer was designated to be on standby to rapidly supply vaccines during a pandemic, POLITICO’s Sarah Owermohle reports. “While a logical and innovative idea, subsequent execution of the CIADM program and operational investment by all administrations fell short of what was needed to maintain capability in case such a threat arose,” Emergent said Thursday. The end of the Obama-era agreement leaves Texas A&M University as the only manufacturer available under a BARDA program for the government to rapidly scale up vaccine and drug production to react to a public health crisis or biologic threats. VAX-OR-TEST MANDATE TO KICK IN AFTER HOLIDAYS — The Biden administration’s Covid-19 immunization mandates for private employers, federal contractors and certain health care workers won’t be enforced until after the holiday season, POLITICO’s Rebecca Rainey reports, after weeks of pressure from businesses fearful of worker shortages and supply chain snafus. That grace period isn’t enough to keep red states from pushing back hard against the requirements; 19 have already sued the administration over the mandates for federal contractors, which don’t include a testing carveout. And Florida Gov. Ron DeSantis, a Republican foil to Biden, quickly vowed to join in the legal morass. GOP SENATORS PRESS OFFICIALS ON ‘NATURAL’ COVID IMMUNITY — Senate HELP Committee Republicans were stuck on a tricky topic during Thursday’s Covid-19 pandemic response hearing: What’s up with natural immunity? Some members seized on a data review the CDC published last week outlining what is known about vaccine-induced immunity compared to that conferred by viral infection. While the agency couldn’t draw many firm conclusions about post-infection immunity, senators pointed to data suggesting that previously infected individuals are at low risk for reinfection for at least six months after falling ill — thus questioning why those people should have to submit to federal vaccination mandates for certain employers. “If we don’t know that natural immunity confers protection against future infection, it’s because we’ve decided not to look,” said Sen. Bill Cassidy (R-La.). CDC Director Rochelle Walensky and White House chief medical adviser Anthony Fauci told senators it’s not that simple: Immunity depends on how long ago a person was infected and how ill they actually were, as asymptomatic and mild cases who may not have gone to the doctor have less protection conferred from that infection than someone who was much sicker. Vaccine manufacturers and researchers also have yet to define the benchmark level of antibodies and memory cell responses that mean an individual is adequately protected from disease. What we do know: The best combination of protection in laboratory-speak is having been infected and then getting vaccinated, Fauci said. “That looks like the most powerful of the protective responses,” he said. Wouldn’t be a Covid hearing without it: Fauci and Sen. Rand Paul (R-Ky.) dueled once again over NIH funding of research in China, Lauren writes. ‘Acting’ out: Acting Commissioner Janet Woodcock has 10 more days left until she has to step down from her caretaker role, unless President Joe Biden nominates someone else for the spot. Will she stay or will she go? “Sorry, I can’t comment on that,” she told Lauren. NOVAVAX: STILL BULLISH ON SHOT AUTHORIZATION — President and CEO Stan Erck maintained during a third-quarter earnings call Thursday that the company will file for emergency-use authorization from the FDA for its Covid-19 vaccine by the end of the year. He said he couldn’t predict how long regulators will take to evaluate its applications, one of those being its just-completed submission for emergency-use listing at the World Health Organization. But Erck did divulge that the company had “communication” with FDA this week and plans to meet “later this month” for more clarity on how to complete the EUA petition. NOW LIVE! POLITICO Pro has launched the Project Library to give Premium users a head start when tracking critical issues moving across the policy landscape. Our expert editors have created sample projects that feature the leading players, bills and regulations, news articles and Premium analysis content on key topics. Check out our Project on Covid-19 vaccines, which features contact info for key power players at the CDC, DataPoints on vaccination rates and a Pro Analysis looking at how vaccine distribution has progressed. There’s also our Project on FDA decision-making, which features Pro coverage of recent FDA regulatory efforts and recommendations, key contacts at the agency and a Pro Analysis looking at the agency’s take on issues like electronic cigarette regulation. | 
