STAT+: Pharmalittle: J&J denies design of its Covid-19 shot may explain blood clots; second trial against opioid makers begins

Good morning, everyone, and welcome to another working week. Once again, another delightful weekend respite has come and gone, leaving us with the familiar challenge of tackling virtual meetings, deadlines, and a growing to-do list. No doubt, you can relate, yes? So please join us as we enjoy another cup of stimulation — as you know, a prescription is not required — and dig in for another busy day. Meanwhile, here are a few items of interest. Hope you have a smashing day and do stay in touch. …

Scientists at Johnson & Johnson (JNJ) refuted an assertion in the New England Journal of Medicine that the design of their Covid-19 vaccine, which is similar to the AstraZeneca (AZN) shot, may explain why both have been linked to very rare brain blood clots in some vaccine recipients, Reuters says. A letter published in the medical journal by University of Nebraska researchers asserted that the rare blood clots “could be related to adenoviral vector vaccines.”

Emergent BioSolutions (EBS) reached an agreement with the Food and Drug Administration not to manufacture any new material at its facility in Baltimore, MarketWatch says. The FDA began inspecting the plant last week, after J&J found Emergent workers had confused ingredients for its Covid-19 vaccine with ones used in making the vaccine developed by AstraZeneca and Oxford University. J&J immediately took over production and imposed its own experts and technicians to oversee it.

The tiff between AstraZeneca and the European Union may be getting worse, WION says. French Industry Minister Agnes Pannier-Runacher told a radio station in France that the EU will most probably not renew its contract with AstraZeneca for coronavirus vaccine. A final decision has not been made, but the minister said “it is highly probable” the EU will not order further doses. “We have not started talks with Johnson & Johnson or with AstraZeneca for a new contract, but we have started talks with Pfizer (PFE),BioNTech (BNTX) and Moderna (MRNA).”

India is set to accept a request from the Serum Institute of India for a $400 million grant to boost its capacity to make the AstraZeneca Covid-19 vaccine, according to Reuters. Serum Institute, the world’s biggest vaccine maker, sought the funds to increase its monthly capacity to more than 100 million doses by the end of May, from up to 70 million currently. The country has administered more than 112 million doses of the shot so far, but the Indian government is struggling to meet demand for the drug from many states as infections spread rapidly.

Pfizer has backed down over its controversial demand that the South African government put up sovereign assets guaranteeing an indemnity against the cost of any future legal cases tied to its Covid-19 vaccine, The Bureau of Investigative Journalism reports. During Covid-19 vaccine negotiations, the company sought indemnity against civil claims from citizens who had experienced adverse vaccine effects – meaning that the government would have to cover the costs instead.

Ottawa paid nearly twice what other countries did for the AstraZeneca Covid-19 vaccine, iPolitics writes, citing an email from a senior member of the prime minister’s staff. News reports last fall suggested that countries were buying vaccines from AstraZeneca for as little as $3, but Canada agreed to buy its first 20 million doses from the company for $8.18 apiece, Rick Theis, director of policy and cabinet affairs in the Prime Minister’s Office, wrote to colleagues the day before Prime Minister Justin Trudeau announced the deal.