- 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
- EU sues AstraZeneca over breach of COVID-19 vaccine supply contract (reuters.com)
The European Commission said on Monday it had launched legal action against AstraZeneca for not respecting its contract for the supply of COVID-19 vaccines and for not having a "reliable" plan to ensure timely deliveries...Under the contract, the Anglo-Swedish company had committed to making its "best reasonable efforts" to deliver 180 million vaccine doses to the EU in the second quarter of this year, for a total of 300 million in the period from December to June...But AstraZeneca said in a statement on March 12 it would aim to deliver only one-third of that by the end of June, of which about 70 million would be in the second quarter. A week after that, the Commission sent a legal letter to the company in the first step of a formal procedure to resolve disputes...Read More
- FDA orders shutdown at Emergent’s troubled plant 2 weeks after handing J&J the keys (fiercepharma.com)
Johnson & Johnson’s takeover of COVID-19 vaccine manufacturing at an error-prone Emergent BioSolutions plant in Baltimore didn’t last long...Two weeks after the U.S. stepped in and handed control of vaccine manufacturing at the plant to J&J, Emergent agreed to temporarily halt producing new drug substance there...READ MORE
- Pfizer CEO says third Covid vaccine dose likely needed within 12 months (cnbc.com)Moderna watches for 'waning immunity' as new data show durable vaccine protection (biopharmadive.com)
Pfizer CEO Albert Bourla said people will "likely" need a booster dose of a Covid-19 vaccine within 12 months of getting fully vaccinated..Bourla said it's possible people will need to get vaccinated against the coronavirus annually..."A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role,"...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
- U.S. Lifts Pause, Will Restart J&J Vaccinations with Warning (nationalreview.com)FDA, CDC Decide Benefits of J&J Vaccine Outweigh the Risks (biospace.com)
The United States will resume Johnson & Johnson COVID-19 vaccinations after health officials lifted an 11-day pause on the shots at the recommendation of a Centers for Disease Control and Prevention advisory panel...The panel voted 10 to 4 to recommend restarting the vaccinations, saying the benefits of the shot outweigh the rare risk of blood clots. However, the group suggested that the vaccine include a warning about the increased risk of the very rare but severe blood clots...READ MORE
- More therapeutics but no surge in vaccine for Michigan, Biden administration says (reuters.com)Michigan Governor Says COVID-19 Infections Could Be Dropping (usnews.com)
The White House said on Monday it was prepared to send additional therapeutic treatments to the state of Michigan, which is experiencing a worrying number of COVID-19 cases, but declined to promise more vaccine as the state has sought...White House coronavirus adviser Andy Slavitt told reporters the U.S. government would work to ensure that states such as Michigan were ordering the full amount of vaccine that was available to them but said that shifting distribution was not in line with the administration’s public health strategy...READ MORE
- U.S. to send more than $100 mln in COVID supplies to India (reuters.com)
The United States is sending supplies worth more than $100 million to India to help it fight a surge of COVID-19 cases...The supplies...include 1,000 oxygen cylinders, 15 million N95 masks and 1 million rapid diagnostic tests...The United States also has redirected its own order of AstraZeneca manufacturing supplies to India, which will allow it to make over 20 million doses of COVID-19 vaccine...READ MORE
- Johnson & Johnson says it has negotiated Covid-19 vaccine warning label with FDA (msn.com)
Johnson & Johnson said Friday that it has negotiated a warning label for its Covid-19 vaccine to make health care providers aware of a potentially increased risk of rare but severe blood clots and low platelet counts...The vaccine maker revealed the warning text, which it said the Food and Drug Administration had agreed to, during a presentation Friday before a Centers for Disease Control and Prevention vaccine advisory panel...Neither the FDA nor CDC has said they will adopt a warning label...READ MORE
- As blood clot concerns mounted, J&J reached out to rival COVID-19 vaccine makers to form alliance: WSJ (fiercepharma.com)
Johnson & Johnson reached out to vaccine rivals—including AstraZeneca, Moderna and Pfizer—last week, hoping to join forces to study cases of rare and severe blood clots cropping up in some vaccinated people...The goal: to forge an alliance that would communicate the vaccines' benefits and risks to allay fears among the public...Regulators were already investigating a small number of cases possibly linked to AstraZeneca's vaccine...the FDA and its European counterparts said they were examining four cases in people dosed with the J&J shot...READ MORE