FDA SET TO APPROVE PFIZER’s VACCINE — The agency is poised to announce the full approval of the Pfizer-BioNTech coronavirus vaccine for adults as soon as this morning , in a much-anticipated decision that would make it the first Covid-19 shot to get the federal government’s official stamp, Adam and Erin Banco scooped. The approval has long been considered a formality, after months of real-world evidence confirmed the vaccine as safe and highly effective. The FDA first authorized it for emergency use last December, and hundreds of millions of shots have since gone out around the world. But it’s critical to President Joe Biden’s vaccination campaign for two key reasons: First, the full sign-off is expected to prompt a wave of vaccine mandates from major employers, universities and institutions that will help boost the vaccination rate amid the Delta-fueled surge. And second, a portion of Americans who have held out for months may now have the assurance they need to seek out the vaccine. Polling earlier in the summer has suggested that roughly 30 percent of those who are still unvaccinated would be more likely to get a fully approved shot. Those could be important developments in beating back Delta’s rapid spread ahead of the colder months. Vaccinations are already accelerating, with the U.S. twice hitting 1 million daily shots last week for the first time since June — a jump that officials have attributed at least in part to Covid-19’s resurgence. But caseloads are still rising too, hitting levels on par with what the U.S. experienced back in February. And early indications are that infections are spreading rapidly among school-aged children going back to class — jeopardizing Biden’s vow to ensure a full year of in-school learning. With full approval in hand, more corporations are likely to feel comfortable making vaccination a condition of employment. And it could kick off efforts across the nation to add the Covid-19 shot to the list of vaccines that students must get before they go to school. Of course, it won’t solve everything. In the least-vaccinated — and often deepest red — parts of the country, there’s likely to be little appetite for anything approaching a vaccine mandate. A chunk of the unvaccinated are also likely to point to the approval as a new excuse not to get the shot, arguing that it happened too fast. Yet for a Biden administration that’s struggled in recent weeks to contain a virus they’d hoped would be largely defeated by now, the vaccine’s approval offers a bit of good news — and the prime opportunity for a high-profile victory lap. BIDEN LEANS ON DRUG PRICING TO SELL SPENDING BILL — The White House is trying to build support for its $3.5 trillion spending package by selling skeptical Democrats on the one element that’s projected to save money: a sweeping drug price overhaul. Administration officials have emphasized the need to slash drug prices during conversations with lawmakers , POLITICO’s Laura Barrón-López reports, pointing in particular to the popularity of permitting Medicare to directly negotiate the cost of medicines. The provision has consistently won strong support from key voting blocs — evidence that Biden aides say proves passing the spending bill will be crucial to ensuring Democrats keep the House in 2022. Lowering drug costs would counter GOP attacks on Biden’s economic record, the White House believes, and have a more immediate impact than anything in Congress’ bipartisan infrastructure deal. The new data point: The firm run by Biden campaign pollster Celinda Lake published survey results Friday showing 87 percent of voters over the age of 65 favor Medicare negotiation. The poll also found that 51 percent of seniors were more likely to vote for a Democratic candidate who supported the proposal. The provision is also key for another reason: It’s projected to create massive savings. When Medicare negotiation language was included in House Democrats’ 2019 drug pricing bill, the Congressional Budget Office said it would save more than $450 billion alone over a decade. Securing that offset is critical for a White House that has vowed to ensure the $3.5 trillion package is paid for in full. Still, the concept is a hard sell for centrist Democrats. The party only included it in their 2019 bill after extensive negotiations — and with the knowledge it had no chance of becoming law under the Trump administration. Since then, moderates have clung to concerns it would harm innovation in the drug industry. And the deep-pocketed pharmaceutical lobby has proven willing to amp up the pressure to keep the government from gaining greater leverage over prices. |