- Pfizer, AstraZeneca COVID vaccines probed in Europe after reports of heart inflammation, rare nerve disorder (fiercepharma.com)
Europe’s drug regulator says it’s evaluating an assortment of potential side effects following inoculation with leading COVID-19 vaccines, including heart inflammation, facial swelling and a rare nerve-degenerating disorder. Yet in most circumstances, it’s not clear whether the vaccines are to blame...In AstraZeneca’s case, the European Medicines Agency’s safety committee...said it’s examining reports of Guillain-Barre syndrome among people who received the drugmaker’s COVID-19 vaccine...The agency is tracking the data for all coronavirus shots as part of its routine safety procedures...READ MORE
- Eli Lilly faces employee complaints, FDA troubles at factory making COVID-19 drug: report (fiercepharma.com)
Quality control problems have already plagued one COVID-19 vaccine manufacturer in Baltimore, Maryland. Now, it appears they’re threatening to trip up a major pandemic therapeutic supplier as well...Eli Lilly employees have accused an executive at the drugmaker’s Branchburg...manufacturing site of altering FDA-required documents in an effort to downplay serious quality control problems...citing internal complaint documents...The complaint, dated April 8, said the executive tasked with quality controls rewrote findings from Lilly’s technical experts at the facility, which produces doses of the company’s COVID-19 antibody treatment bamlanivimab, in order to make them look more favorable...READ MORE
- CVS adding 14 new markets to its Project Health preventive screening program (fiercehealthcare.com)CVS Health launches $100M digital health investment fund (fiercehealthcare.com)
CVS Health is expanding its program to offer no-cost, community-based screenings to 14 more markets...Project Health, which is now in its sixteenth year, offers a slew of free biometric screenings at CVS Pharmacy locations, including blood pressure, glucose levels and cholesterol. Patients can then meet with a nurse practitioner, who can provide additional guidance and referrals for treatment if needed...The program is also launching four new mobile units, CVS said, and anticipates providing 1,700 screening events across its 32 markets by the end of the year...READ MORE
- Johnson & Johnson scores in talc appeals as NJ court knocks down $117M verdict (fiercepharma.com)
Johnson & Johnson has been hit with billions in talc verdicts, but it's had mixed success in appeals. With a new decision...the company chalked up its latest appeals win...A court in J&J's home state of New Jersey struck down a $117 million verdict against the drugmaker originally handed down there in 2018...The court ruled that the trial judge shouldn’t have allowed certain expert testimony, so J&J and its talc partner Imerys—which has since declared bankruptcy—deserve another trial...READ MORE
- Pfizer’s COVID-19 vaccine scores FDA nod in adPfizer’s COVID-19 vaccine scores FDA nod in adolescents, enabling a wider rolloutolescents, enabling a wider rollout (fiercepharma.com)
In a first for the U.S., the FDA has authorized the use of Pfizer's BioNTech-partnered COVID-19 vaccine for use in adolescents between the ages of 12 and 15—months ahead of the upcoming school year in the fall...The FDA will amend the existing emergency authorization for the vaccine, which was first issued in December, the agency said. Pfizer’s vaccine is currently the only shot allowed in the U.S. for Americans as young as the age 16. The vaccine's two-dose regimen will be the same for adolescents as it is for adults, the agency said...READ MORE
- Denmark removes J&J from vaccination program over clot fears (apnews.com)
Denmark...removed the single-dose Johnson & Johnson COVID-19 shot from its vaccination program to investigate reports of rare but potentially dangerous blood clots...Denmark, which has been very cautious with all vaccines, has already taken the AstraZeneca shot out of its vaccination program for the same reason. Both the J&J and AstraZeneca shots are made with similar technology...The Danish Health Authority said in a statement that it “has concluded that the benefits of using the COVID-19 vaccine from Johnson & Johnson do not outweigh the risk of causing the possible adverse effect.”...READ MORE
- British regulator cites 41 more blood clot reports following AstraZeneca shots (reuters.com)
Britain’s medicine regulator on...said there had been a further 41 reports of rare blood clots after doses of AstraZeneca’s COVID-19 vaccine, but that the benefits of the shot continued to outweigh the risks for the majority of people...In a weekly update on side effects from COVID-19 vaccines, the Medicines and Healthcare products Regulatory Agency said there were a total of 209 clots with low platelet counts following vaccination with AstraZeneca's shot, compared to a total of 168 reported last week...READ MORE
- Pfizer eyes $26B in COVID-19 vaccine sales for the year, with $3.5B already in the bag (fiercepharma.com)Pfizer Owes Massive $14.6 Billion Q1 Revenues to Vaccine Rollout (biospace.com)
In the first three months of 2021, Pfizer's COVID-19 vaccine pulled in as much revenue as some pharma blockbusters make in an entire year. That’s just the beginning, as Pfizer eyes sales from more than a billion additional doses before the end of 2021...The mRNA-based shot Comirnaty—first to market in the U.S.—reeled in $3.5 billion globally in the first quarter...For the full year, Pfizer projects a whopping $26 billion in Comirnaty sales, based on the 1.6 million doses the company has pledged worldwide...READ MORE
- Emails show high-powered teachers union pressured CDC to change school reopening guidance (washingtonexaminer.com)The CDC’s cruel, irrational guidance traps our kids in the forever pandemic (nypost.com)
The American Federation of Teachers successfully lobbied the Centers for Disease Control and Prevention to change its guidance on school reopenings, emails show...As the CDC was preparing to issue guidance that it was safe to reopen schools fully in February, emails obtained through a Freedom of Information Act request revealed that the AFT was behind the scenes, lobbying the agency and the Biden administration to adjust the guidance to make it friendlier to school closures and hybrid learning...The CDC was preparing to update its guidance to reflect its belief that schools could fully reopen, regardless of community spread of COVID-19...READ MORE
- Just how much COVID-19 vaccine money is on the table? A whopping $157B through 2025, report says (fiercepharma.com)
Drugmakers who seized the opportunity to develop vaccines against the coronavirus are on their way to reaping significant revenues...In its annual forecast for global drug spending, the IQVIA Institute for Human Data Science put the figure at $157 billion through 2025...In regard to global COVID-19 vaccine spending, IQVIA projects roughly $53 billion this year and $51 billion in 2022. The group sees a precipitous drop in total spending in 2023, to roughly $23 billion...READ MORE