Covid-19 roundup: Duke demands Covid vaccine — or else; FDA resumes Eli Lilly's mAb use in 22 states after pause for variant uptick
Duke University has come up with one of the most severe vaccine mandates in the books. Their message to more than 22,000 faculty and staff: Get a jab of either the J&J, Moderna or Pfizer/BioNTech vaccines, or get fired. And don’t come back looking for a job later.
Exemptions for medical and religious reasons will be considered, but anyone allowed to take that route will also be subjected to daily monitoring for symptoms and weekly tests, according to their statement to staff, sent to Endpoints News.
The bottom line from provost Sally Kornbluth and administration VP Kyle Cavanaugh:
Vaccination is the best way to protect yourself and your loved ones from serious illness related to COVID-19, and it is (the) only way we will bring an end to this pandemic.
Duke is already close to its goal, with 91% of staff and faculty vaccinated.
News of the Duke demand spread fast on Monday morning, coming as a whole host of businesses — including a wide swathe of biopharma — have been mandating a Covid-19 vaccine. Now that Pfizer/BioNTech has a full approval, the hope among many experts is that more mandates can push wider adoption at a time the Delta variant has been racking up a surging wave of new infections.
Houston Methodist was one of the first health centers to mandate a vaccine, firing or accepting resignations from dozens of workers. And other companies have been ratcheting up the pain for noncompliance. That includes Delta, where health insurance will now cost more for the uninsured. — John Carroll
Eli Lilly gets a green light to resume antibody sales
In Eli Lilly’s Q2 call, their execs revealed that sales of its monoclonal antibodies for Covid-19 treatment were slashed after distribution was halted nationwide. Now, two months since the shipments were paused, the FDA is resuming its use in a little less than half of the US.
The FDA has now specified that Eli Lilly’s mAb combo of bamlanivimab and etesevimab is allowed for use in states and territories in which the combined frequency of variants that are resistant to the drug are less than 5%, the agency announced.
While the antibodies were deemed ineffective against the Beta and Gamma variants — which were trending upward when distribution was first halted — the cocktail can still neutralize the Delta and Alpha variants. Given the dominance of Delta (and relative fall of Beta and Gamma), it appears Lilly’s drugs can once again play a role in the pandemic.
There are 22 states in which that applies: Colorado, Connecticut, Illinois, Indiana, Iowa, Kansas, Maine, Massachusetts, New Hampshire, Michigan, Minnesota, Missouri, Montana, Nebraska, North Dakota, Ohio, Rhode Island, South Dakota, Utah, Vermont, Wisconsin, and Wyoming. On Friday, the FDA and the HHS’ Assistant Secretary for Preparedness and Response started distribution of both bamlanivimab and etesevimab together and etesevimab alone.
The two mAbs were first authorized for emergency use by the FDA on Feb. 9 for use in patients ages 12 years and older, Covid-19 positive and at risk of hospitalization. But as the Beta and Gamma variants became more frequent, the distribution of the combo was halted, first in nine states — including Oregon, Massachusetts and Florida — where the frequency of variants was higher than 10%, then through the entire country.
The list of places where the use of the mAb is not allowed includes Washington DC, American Samoa, Guam and Puerto Rico, among a number of states.
Sales of the mAb were $148 million in the second quarter — a far cry from the $809 million the drugs posted in Q1 — after the US halted distribution of the combo amid a rise in variants. The pause is estimated to cost Eli Lilly about $375 million, according to one biotech analyst.
The Delta variant has become the dominant variant of the virus in the US, according to the CDC. Based on assays, bamlanivimab and etesevimab are expected to be effective against the Delta and Alpha variants, but not the Gamma, Beta or Delta-plus variants.
States and territories that already have received supply but aren’t currently permitted to administer the treatment are allowed to hold on to it for future use, the FDA said. Bamlanivimab and etesevimab are just one of three mAb treatments authorized to treat Covid-19. Regeneron’s Regen-Cov and GlaxoSmithKline/Vir’s sotrovimab are still able to be used without any restrictions.
FDA also revoked the EUA for bamlanivimab alone in April because it was no longer as effective as the combo therapy. — Josh Sullivan
White House sticking with 8-month booster shot recommendation
NIAID’s Anthony Fauci said Sunday that the Biden administration is “sticking with” its recommendation for a third dose of the coronavirus vaccine eight months after receiving the original shots, according to Axios. The Biden administration recently announced it would begin offering booster shots to stay ahead of declining vaccine effectiveness.
His comments were in direct contradiction to reports that the White House planned to call for booster shots six months following the second mRNA jab instead.
“If the data tells us differently, we’ll make adjustments accordingly,” Fauci said on ABC’s “This Week”.
Fauci’s statements come as the US sees an increase in Covid cases — mostly due to the infectious Delta variant. In the last 28 days, Johns Hopkins University data show that the US reported almost 3.8 million confirmed cases. — Paul Schloesser
Gottlieb expects Pfizer Covid-19 vaccine approval for kids under 12 by early winter
Former FDA Commissioner Scott Gottlieb said on CBS’s “Face the Nation” Sunday that the Pfizer vaccine could be approved for kids ages 5-12 by late November or early December of this year.
Gottlieb, who is on the board of directors of Pfizer, said that Pfizer “is going to be in a position… to file data with the FDA at some point in September and then file the application potentially as early as October. So that’ll put us on a time frame where the vaccine could be available at some point, late fall, more likely early winter, depending on how long FDA takes to review the application.”
Data on the vaccine in children between the ages of 2 and 5 will be available by November, Gottlieb said. — Paul Schloesser
Pfizer bolsters marketing team to approach vaccination push
Following its full FDA approval, Pfizer has made it a priority to market its Covid-19 vaccine, and it’s hiring more team members to promote it.
The drugmaker has posted several positions on LinkedIn, The Financial Times first reported, including a senior director for its US Covid launch and a senior manager for US Covid consumer marketing. The jobs are being created among a flurry of competition from vaccine makers for booster shots.
Boosters will become available in the US on Sept. 20 for those who are immunocompromised, and have received either the Moderna or Pfizer-BioNTech jab. Pfizer declined to talk to the FT about the depth or duties of the new team, but it’s expected to market the vaccine through online social media, TV ads and billboards. It’s been working with New York-based ad agency Ogilvy. — Josh Sullivan
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