Pfizer/BioNTech’s jointly developed bivalent COVID-19 vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and is designed to target both the original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 strains.

In each dose of the booster vaccine, 50% of the vaccine targets the original virus strain and the other 50% specifically targets Omicron (BA.4-5).

The updated booster is the second bivalent vaccine produced by Pfizer/BioNTech to be given MHRA approval, having successfully met the regulator’s criteria for safety, quality and effectiveness.

The approval is supported by evidence provided about the original Pfizer/BioNTech COVID-19 vaccine and its adapted vaccines, including extensive safety and effectiveness data for the original vaccine, clinical data from the bivalent original/omicron BA.1 vaccine and safety data from an ongoing clinical trial.

The data demonstrated that the most common side effects recorded with the new bivalent vaccine were the same as those seen for other versions of the vaccine. It was reported that side effects were typically mild and self-resolving, and no new safety concerns were found.

The updated results, announced on 4 November, from the phase 2/3 clinical trial demonstrated a substantially higher immune response in adults, compared to the original vaccine.

Sanofi and GSK’s next-generation COVID-19 booster vaccine, VidPrevtyn Beta, has been approved by the European Commission (EC) for adults aged 18 years and older.

Shipments of the Beta-targeting booster are ready to be distributed to European countries as per advance purchase agreements, the companies said in a statement, in time for autumn/winter COVID-19 vaccination campaigns.

The approval follows the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion of the booster.

This was based on positive results from two ‘immunobridging’ trials comparing the immune response induced by Sanofi/GSK’s new booster with currently approved vaccines.

In the independent COVIBOOST study, VidPrevtyn Beta generated a higher immune response than Pfizer/BioNTech’s booster and Sanofi/GSK’s first-generation booster, both of which target the original D614 parent strain.

In the study, which included 247 adults, all three vaccines also elicited neutralising antibodies against the Omicron BA.1 variant, with the highest responses generated by the Sanofi/GSK next-generation candidate, one month after injection.

The companies reported that VidPrevtyn Beta elicited around 2.5 times more neutralising antibodies against Omicron BA.1 and, in an exploratory analysis, against BA.4/BA.5 strains than the mRNA COVID-19 booster comparator.
Side effects were usually mild and cleared within a couple of days after vaccination.

Novavax’s conditional marketing authorisation for its COVID-19 vaccine, Nuvaxovid, has been expanded for use as a booster in adults aged 18 years and older by the UK Medicines and Healthcare products Regulatory Agency.

The decision was based on positive results from two phase 2 trials, conducted in the US and Australia and South Africa, and from the UK-sponsored COV-BOOST trial.

As part of the phase 2 trials, healthy adults were given a single booster dose of Nuvaxovid approximately six months after their first two-dose vaccination series of Novavax’s vaccine.
The study showed that the third dose offered better protection against the original strain of SARS-CoV-2 that was equal to, or better than, the protection offered in phase 3 clinical trials, the company reported.

In the COV-BOOST trial, antibody levels increased when Nuvaxovid was given as a third booster, after a primary two-dose vaccination series of an mRNA vaccine or adenoviral vector vaccine had been given.

In the Novavax-sponsored trials, adverse reactions to the booster generally lasted for approximately two days, the company reported. Additionally, adverse reactions increased after all three doses of Nuvaxovid, reflecting the increased immune response seen with a third dose.

Moderna’s two bivalent Omicron-targeting booster candidates, mRNA-1273.214 and mRNA-1273.222, have a more effective antibody response than a booster dose of the company’s prototype vaccine, mRNA-1273, against Omicron BA.4/BA.5 subvariants in phase 2/3 clinical trials.

Data from the studies showed that the two Omicron-tailored boosters, both at a 50µg dose, produced a higher antibody response against BA.4/BA.5 compared to a 50µg booster dose of mRNA-1273.

The results build upon the data recently published in the New England Journal of Medicine that confirmed mRNA-1273.214 – the company’s BA.1 bivalent vaccine – had a more effective antibody response against BA.1 compared to a booster dose of mRNA-1273.

All participants had a similar response, regardless of prior infection, and higher antibody levels lasted for at least three months, according to Moderna.

Adverse reactions for both vaccines were similar or lower to those of a second or third dose of the original vaccine. Additionally, no new safety concerns were identified after approximately one month and three months of follow-up, respectively.

In an exploratory analysis, however, the company said levels of neutralising antibody response dropped nearly five-fold against the emerging BQ.1.1 subvariant when compared with BA.4/BA.5, in an analysis of approximately 40 people, although the virus neutralising activity demonstrated by both bivalent vaccines remained ‘robust’.

Sobi’s Kineret (anakinra) has been given Emergency Use Authorisation by the US Food and Drug Administration to treat adults hospitalised with COVID-19 who have pneumonia.

These patients require supplemental oxygen and are at risk of developing severe respiratory failure.

The FDA’s decision was based on positive results from the SAVE-MORE phase 3 trial, which evaluated the safety and efficacy of a daily dose of Kineret for up to ten days.

The study found that when patients hospitalised with COVID-19 were treated early with Kineret, the drug reduced the risk of disease progression by 64%.

Kineret also reduced the risk of severe disease by 54% and meant patients could be moved out of intensive care four days sooner, on average, and could be released from hospital a day sooner.

Kineret is an anti-inflammatory drug that neutralises the biological activity of both cytokines IL-1α and β, which play a role in COVID-19-induced hyperinflammation. Blocking these cytokines early in the course of the hyperinflammatory phase can have an important impact on COVID-19 disease progression, according to Sobi.

Kineret has already been approved to treat patients with COVID-19-related pneumonia in the EU, where it can also be used to treat adults with rheumatoid arthritis, in combination with methotrexate.