Covid-19 roundup: FDA addresses risk of excessive bleeding after J&J vaccine; Novavax vaccine gets OK in South Korea
The FDA has added a new risk to the fact sheet for J&J’s Covid-19 vaccine: immune thrombocytopenia, a condition that can lead to easy or excessive bruising and bleeding.
Regulators issued a letter to J&J on Tuesday alerting it of the change.
“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of immune thrombocytopenia (ITP) during the 42 days following vaccination,” the letter states.
While the chance of experiencing immune thrombocytopenia after vaccination is low, the FDA noted, individuals who have a history of ITP should consult their vaccine providers before receiving the shot, according to the updated fact sheet.
Those who have already received the jab should seek medical attention right away if they experience unusual or excessive bleeding, easy or excessive bruising, or tiny blood spots under the skin beyond the site of injection.
The news comes weeks after the CDC officially recommended that Americans receive one of the mRNA vaccines over J&J’s vaccine due to renewed concerns about rare but sometimes fatal blood clots.
Thrombosis occurs when blood clots block blood vessels. The FDA and CDC put a hold on J&J’s vaccine back in April to assess the risk of such blood clots but ended up lifting the pause less than two weeks later after deciding that the shot’s benefits still outweigh the risks. But during a recent ACIP meeting, it was revealed that there are more cases of thrombosis with thrombocytopenia syndrome (TTS) in those who received the J&J vaccine than previously thought
The J&J shot will still be available to those who are unable or unwilling to get an mRNA vaccine.
Novavax vaccine gets OK in South Korea
Novavax has swung an OK for its Covid-19 vaccine in South Korea, where it will be manufactured and marketed by SK bioscience, the company announced on Wednesday.
The shot — which is now the first protein-based Covid vaccine authorized for use in South Korea — will be available to adults 18 years and older. And SK bioscience already has an advanced purchase agreement with the government for 40 million doses, according to Novavax.
“Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold,” CEO Stanley Erck said in a statement.
It’s still unclear how the vaccine will fare against the Omicron variant, which is spreading rapidly around the world.
Upon authorizing the shot at the end of December, the EMA said:
“Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,”
The shot — also dubbed Nuvaxovid in South Korea — has also received authorization from the WHO, and in India, Indonesia and the Philippines.
But despite insisting for months that the company was just a step or two away from its regulatory filing in the US market, Novavax has still not filed with the FDA.
The company has struggled to assure regulators of its vaccine candidate’s potency and purity, pushing back the timing of submitting its application to the FDA all summer. On Wednesday, the company said it was still a month away from filing in the US.
Pfizer releases new data supporting co-administration of its Covid-19 vaccine and Prevnar 20
New Phase III data from Pfizer suggest its Covid-19 vaccine can be co-administered with its recently approved next-gen pneumococcal vaccine Prevnar 20, according to the company.
Prevnar 20, which was approved back in June, covers all 13 strains that Prevnar 13 does, plus 8, 10A, 11A, 12F, 15B, 22F and 33F.
Pfizer tested the shots in 570 adults, who either received both vaccines at the same time, or either shot plus a placebo. Responses elicited by Prevnar 20 for all serotypes were similar when given with a dose of the Covid vaccine or with placebo, Pfizer said. Responses to a booster dose of the Covid vaccine were also similar when given with Prevnar 20 or placebo.
The safety profile for both shots administered together “generally reflected that observed with the Pfizer-BioNTech Covid-19 Vaccine booster dose,” the company said in a statement.
“Pfizer is steadfast in its commitment to address the burden of certain respiratory diseases while raising awareness of the importance of adult immunizations,” Kathrin Jansen, Pfizer’s SVP and head of vaccine R&D, said in a statement.
Pfizer isn’t the only drugmaker researching vaccine combinations. The CDC has already said that it is safe to administer currently available Covid-19 vaccines along with the flu shot. Moderna and Novavax have also said they’re working on combination Covid and flu shots.