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Product Development

COVID Roundup: No vaccine resistance from a mutation in U.K., South Africa rapid transmission variants; plus Moderna vaccine gains U.K. approval

Jan 9, 2021 | 1:20 AM GMT

Mutation in rapid transmission strains doesn’t confer resistance
University of Texas Medical Branch and Pfizer scientists showed in a paper published Thursday in bioRxiv data suggesting Comirnaty’s efficacy isn’t affected by the N501Y spike mutation present in rapidly spreading SARS-CoV-2 variants in the U.K. and South Africa.

The implications extend to vaccines from Moderna Inc. (NASDAQ:MRNA) and others, which were based on the same viral isolate and incorporate the same spike-stabilizing mutations.

Sera from 20 people vaccinated with 30 µg Comirnaty (BNT162b2), from BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE), in a Phase I/II/III trial neutralized at similar titers the wild-type isolate on which the vaccine was based and a derivative engineered to have the N501Y mutation.

The authors acknowledged the findings are limited as the engineered virus “does not include the full set of spike mutations found on the rapidly spreading strains in the UK or South Africa” — variants of the B.1.1.7 and the S.501Y.V2 lineages, respectively.

Another spike mutation of concern present in S.501Y.V2 variants is E484K. Fred Hutchinson Cancer Research Center scientists reported Monday in bioRxiv that the E484K mutation could enable the virus to escape neutralization by sera. Some serum samples from individuals who had been infected by SARS-CoV-2 were ≥10 times less potent at neutralizing E484K variants than wild-type.

Not all samples exhibited the drop in potency, leaving open the possibility that existing COVID-19 vaccines could protect against variants with the E484K mutations.

BioNTech believes that if a SARS-CoV-2 variant arises that Comirnaty doesn’t sufficiently protect against, it could create a modified vaccine within about six weeks.

U.K. approves, buys more Moderna vaccine
The U.K. approved Moderna COVID-19 Vaccine (mRNA-1273) and exercised its option to buy an additional 10 million doses of the mRNA vaccine, bringing the total to 17 million doses. MHRA’s approval is the fifth authorization for Moderna’s vaccine — it’s also authorized in Canada, the EU, Israel and the U.S. — and the third COVID-19 vaccine approved by the agency. The other vaccines approved in the U.K. are COVID-19 Vaccine AstraZeneca (AZD1222), an adenoviral vector vaccine from the University of Oxford and AstraZeneca plc (LSE:AZN; NASDAQ:AZN); and Comirnaty.

CHMP suggestion on sixth Comirnaty dose/vial
EMA’s CHMP recommended updating Comirnaty’s label to clarify that each vial contains six, rather than five, doses. The agency said that to get the extra dose, low dead-volume syringes or needles should be used; and that the dead volume should be no more than 35 µL.

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