ELLA BATES-HERMANS/Stuff
Medsafe has granted provisional approval of the BA.1 and BA.4/5 bivalent version of the Pfizer Comirnaty Covid vaccine.
Medsafe has granted provisional approval of Pfizer’s Omicron BA.1, and BA.4/5 booster vaccines in Aotearoa.
The medicine safety authority’s ‘status of applications’ webpage shows provisional approval was granted to the two bivalent Omicron vaccines on Wednesday, December 21 and is valid until November 3, 2023.
The approved indication (use) was as a booster dose in people over the age of 12 who have previously received at least their primary vaccination course (first two doses) against Covid-19.
Provisional approval does not mean that a decision has been made to use this as part of the Covid-19 vaccination programme, as Medsafe approval is just the first step in the process, a Ministry of Health spokesperson said.
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The Covid-19 Vaccine Technical Advisory Group (CV-TAG) will now provide advice to the ministry “to inform a decision on whether to use the vaccines in New Zealand”.
If approval is granted, bivalent vaccines are expected to be available in the first quarter of 2023.
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The advisory group will also be reviewing the eligibility criteria as part of the approval process.
These new vaccines cause the immune system to create antibodies against both the original variant of SARS-CoV-2 and the Omicron subvariant.
A review of available evidence has concluded these bivalent vaccines “are likely to be more effective against Omicron subvariants than earlier vaccines”, the ministry said on Thursday afternoon.
However, the current vaccines in use continue to be “very effective at reducing the risk of serious illness and death, and we urge people to ensure they are up-to-date with the vaccines they are eligible for”, a spokesperson said.
It comes as the proportion of non-BA.5 variants in Aotearoa continues to increase.
BA.5 accounted for only 33% of sequenced cases in the week ending December 9, with BA.2.75 now the dominant variant (making up 39% of cases), data released by the ministry on Monday showed.
BQ.1.1 made up 14% of sequenced cases in that timeframe and 5% were another variant, XBC.
Gazette notices, outlining conditions for the Omicron vaccines, were published on December 21.
It comes after the ministry last week announced the use of the paediatric Pfizer Covid-19 vaccine would be available for children aged 6 months to 4 years who are at higher risk of severe disease if they were to catch Covid-19.
It is anticipated that the vaccine will be available for severely immunocompromised tamariki in February 2023.
Covid-19: Medsafe grants provisional approval for Pfizer Omicron vaccine - Stuff
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