US FDA clears Moderna, J&J booster shots; backs Covid-19 vaccine mixing

Pfizer and BioNTech said a booster shot of their Covid-19 vaccine restored full protection in a large study, results that are likely to bolster the argument for giving a third dose more widely

The US Food and Drug Administration (FDA) cleared a path for millions more Americans to receive Covid-19 vaccine booster shots, as the nation looks to bolster its defenses and prevent another virus surge.
 

The agency said in a statement on Wednesday that Moderna vaccine recipients 65 and over can receive a third shot, as can adults aged 18 and above who are at high risk of severe Covid or with frequent institutional or occupational exposure to the virus that causes the disease.
 

Additionally, all J&J recipients 18 and older are eligible for a booster shot at least two months after receiving their first dose. 

The agency also allowed each of the available Covid vaccines to be used as a booster dose for eligible individuals following completion of a primary vaccination with a different vaccine.
 

The moves will mean the US has a bigger toolkit to try to limit a potential winter virus rebound. The summer’s delta-variant fuelled spike in infections helped increase urgency to make boosters available, and health officials across the US are eager to forestall a rebound in cases that could cripple hospitals and disrupt work and school this winter. 
 

FDA officials indicated they would also move quickly to expand eligibility for booster shots as more data become available or if breakthrough cases start to rise in younger adults.
 

“We will not hesitate to drop this age range as we see that that benefit clearly outweighs the risk,” said Peter Marks, the head of the agency’s Center for Biologics Evaluation and Research, during a media briefing following the announcement.
 

Moderna shares climbed 0.8 per cent in after-hours trading in New York, while J&J shares gained 0.4 per cent and Pfizer shares rose 0.2 per cent. US-traded shares of Germany-based BioNTech gained 0.9 per cent. 
 

Novartis extends deal to make Pfizer/BioNTech vaccines
 

Novartis has agreed to expand its fill-and-finish support for the Pfizer/BioNTech Covid-19 vaccine by using manufacturingfacilities Ljubljana, Slovenia, to fill at least 24 million doses in 2022, the Swiss drugmaker said on Thursday. Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under sterile conditions for shipment back to BioNTech for distribution. 

UK adds nerve disorder as side-effect of  AstraZeneca

The UK drug regulator added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), as a very rare side effect of the AstraZeneca Covid vaccine, updates on the agency's website showed. Medicines and Healthcare products Regulatory Agency's (MHRA) decision comes after the European medicines agency added GBS as a possible side-effect last month. (Reuters)