Covid-19 roundup: Germany puts J&J on the hotseat for vaccine backorder; Top EMA official suggests forgoing AstraZeneca shot
Shortly after it was announced that the FDA has required J&J to discard tens of millions of Covid-19 vaccines that were contaminated at an embattled Emergent plant in Baltimore, MD, Germany has demanded that the company deliver 6.5 million doses to make up for a shortfall, Reuters reported.
The FDA said Friday that two batches of the drug substance used in J&J’s jab would be released from quarantine after millions of doses were held from distribution at the Emergent site. While that frees up about 10 million doses, The New York Times reported Friday morning another 60 million doses were ordered to be tossed out.
Emergent’s Bayview plant was previously taken over by the FDA, causing a significant shortage in J&J vaccines being shipped to countries in need. Germany has been hit particularly hard, as the country was owed 10.1 million doses of the single-dose jab in the second quarter, the ministry of health told Reuters.
In addition to the quarantined doses, Emergent was forced to halt any further production as the FDA took over the Baltimore Bayview plant to observe its operations.
Top EMA official advises against AstraZeneca’s jab
The EMA’s head of vaccine strategy has recommended the EU avoid AstraZeneca’s vaccine in situations in which an alternative is available, The Brussels Times reported Monday. He also recommended the J&J jab only be used in patients above the age of 60.
Marco Cavaleri made the comments to the Italian newspaper La Stampa over the weekend. Italy restricted the use of AstraZeneca’s vaccine in patients under the age of 60 because of the fear of rare but dangerous blood clots.
When asked if it was better to halt using AstraZeneca altogether for all age groups, Cavaleri agreed, and said that it’s an option many countries are taking into consideration as the supply of mRNA vaccines from Moderna and Pfizer becomes more readily available.
PhIII trial results for Celltrion’s antibody treatment shows positive results
Celltrion’s experimental Covid-19 antibody treatment reduced the treatment period for patients by five days, the company announced Monday.
The trials, which included patients from 13 countries including the US, South Korea, Spain and Romania, were safe, the company said.
Rekirona gained South Korean regulatory approval in February, as it became the country’s first locally made Covid-19 treatment. Phase III trial results showed the antibody reduced the risk of the virus progressing by 70%, Reuters said.
Celltrion plans to submit an application for regulatory approval with both the FDA and EMA in the coming months, The Korea Herald reports.
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Social image: Angela Merkel (AP Photo/Michael Sohn)