Pfizer and German partner BioNTech said on Monday they had sought US authorisation for a Covid-19 vaccine retooled to target the Omicron subvariants.
The request to the Food and Drug Administration was for a so-called bivalent vaccine containing the dominant BA. 4 and BA. 5 variants of the virus, along with the original coronavirus strain. It is intended for ages 12 and above.
Pfizer said it was ready to deliver doses for September under a $3.2 billion deal in place with the US government for 105 million doses, including the Omicron-tailored shots.
“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA. 4, BA. 5 boosters, if authorised,” Pfizer chief executive Albert Bourla said.
Countries including the UK, the US and EU members have been preparing for vaccination campaigns in the autumn to protect against future surges. Britain became the first country to clear a bivalent vaccine, made by Moderna, last week.
The FDA in June asked Covid-19 vaccine makers to tailor shots to target the two subvariants. It said it would not require new studies testing the shots in humans for authorisation, similar to how annual changes to flu vaccines are handled.
A mid-to-late-stage study of Pfizer's older BA. 1-tailored vaccine has shown that the new shot generated a superior immune response against the subvariant compared with the original one.
A study of the BA. 4 and BA. 5 vaccine in people aged 12 years and older is expected to start this month.
Things Heard & Seen
Directed by: Shari Springer Berman, Robert Pulcini
Starring: Amanda Seyfried, James Norton
2/5
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Three tips from La Perle's performers
1 The kind of water athletes drink is important. Gwilym Hooson, a 28-year-old British performer who is currently recovering from knee surgery, found that out when the company was still in Studio City, training for 12 hours a day. “The physio team was like: ‘Why is everyone getting cramps?’ And then they realised we had to add salt and sugar to the water,” he says.
2 A little chocolate is a good thing. “It’s emergency energy,” says Craig Paul Smith, La Perle’s head coach and former Cirque du Soleil performer, gesturing to an almost-empty open box of mini chocolate bars on his desk backstage.
3 Take chances, says Young, who has worked all over the world, including most recently at Dragone’s show in China. “Every time we go out of our comfort zone, we learn a lot about ourselves,” she says.
The Voice of Hind Rajab
Starring: Saja Kilani, Clara Khoury, Motaz Malhees
Director: Kaouther Ben Hania
Rating: 4/5
'Brazen'
Director: Monika Mitchell
Starring: Alyssa Milano, Sam Page, Colleen Wheeler
Rating: 3/5
SPECS
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