Moderna has shared new clinical data evaluating its COVID-19 booster vaccine candidate, mRNA-1273.214 – containing mRNA-1273 (Spikevax) – and a vaccine candidate targeting the Omicron sub-variant.

The analysis shows that the new vaccine offers better protection against Omicron than Moderna’s original vaccine, Spikevax, producing nearly double the neutralising antibody levels.

The vaccine candidate targets two of the virus variants, including Omicron. It met all primary endpoints in the phase 2/3 trial and was well-tolerated by the 437 study participants.

The vaccine contains specific mRNA elements for the spike protein associated with both the Omicron variant and the original SARS-CoV-2 virus. If approved, it could be used as a second booster dose in future vaccine roll-out programmes.

Stéphane Bancel, CEO of Moderna, said: “The preliminary data analysis on mRNA-1273.214 is the second demonstration of superiority of our bivalent booster platform against variants of concern and represents an innovation in the fight against COVID-19.

“Looking at this data alongside the durability we saw with our first bivalent booster candidate, mRNA-1273.211, we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a fall 2022 booster.”

In February 2021 Moderna announced it would update its booster candidates as the SARS-CoV-2 virus continued to evolve. This included monovalent and bivalent candidates targeting multiple variants of concern.

Pfizer and BioNTech have announced recent data from a phase 2/3 trial assessing a third 3µg dose – one-tenth of the adult dosage – of their COVID-19 vaccine for children aged from six months to under five years old.

One of the second endpoints in the trial was vaccine efficacy, which was 80.3% in children aged six months to under five years. This analysis was taken during a period when the Omicron strain was the predominant variant, and was based on ten symptomatic COVID-19 cases identified seven days after the third dose and accrued as of 29 April 2022.

In the phase 2/3 trial, more than 10,000 children aged six months to under 12 years were enrolled at more than 90 clinical trial sites in the US, Finland, Poland and Spain. 1,678 children were given a third dose of the 3µg formulation at least two months after the second dose, when Omicron was the most prevalent strain.

It was found that this dosage of the Pfizer/BioNTech COVID-19 vaccine was well tolerated in the age group and no new safety signals were identified, while most adverse events were noted as being mild to moderate. The immunogenicity, safety and vaccine efficacy data for three doses of the vaccine in children under five years of age remain consistent with the data shown in adults.

According to new preclinical data from the University of Oxford, AstraZeneca’s Evusheld, AZD7442, is effective in protecting against emerging Omicron variants. The findings were reported online on bioRxiv, a preprint server.

These results are consistent with previous data from multiple studies showing that Evusheld retains potent neutralising activity against Omicron BA.2, the current dominant circulating variant, and neutralises all variants tested to date.

Previously circulating SARS-CoV-2 variants have expanded in similar patterns and BA.4 and BA.5, currently the dominant variants in Africa, could spread globally in a similar way.

Approximately 2% of the global population is considered at increased risk of an inadequate response to COVID-19 vaccination and may benefit from the antibody, including people who are immunocompromised, such as cancer patients, transplant patients and anyone taking immunosuppressive medicines.

Evusheld is a combination of two long-acting antibodies derived from B-cells donated by individuals previously infected with the COVID-19 virus. It was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.

Evusheld has marketing authorisation in the European Union and was granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for pre-exposure prophylaxis of COVID-19.

Pressure on COVID-19 vaccine manufacturers is mounting as European Union (EU) governments push to renegotiate contracts, with a caution issued by EU officials that millions of vaccine doses could be wasted.

When vaccines became available earlier in the COVID-19 pandemic, countries urgently vied for supply contracts. However, as the need for vaccines begins to slow in Europe, some countries want to amend their contracts to reduce spending and to prevent receiving more vaccines than are needed.

Detailed in a letter to the European Commission in June 2022, Polish Health Minister Adam Niedzielski, with support from Croatia, Estonia, Bulgaria, Latvia, Hungary, Lithuania and Romania, made calls for a ‘reduction’ in the number of vaccines being ordered.

As contracts were finalised at a time when it was impossible to predict the direction of the pandemic, it is felt that these contracts should be changed as the situation gradually improves.

Leading suppliers of COVID-19 vaccines, Pfizer and Moderna, have agreed to delay some deliveries, but in reaction to this, in the joint letter ministers said that the companies’ proposed postponement was ‘an insufficient solution’ to the issue.

Sanofi and GSK have jointly developed a next-generation COVID-19 booster vaccine candidate, based on Sanofi’s recombinant Beta variant antigen and combined with GSK’s pandemic adjuvant.

Results from the phase 3 trial showed that, 15 days after receiving the Sanofi/GSK vaccine, antibodies had been boosted significantly against multiple variants of concern in adults who previously received mRNA COVID-19 vaccinations.

Specifically against Omicron, the preliminary data demonstrated 40 times as much of an increase against the BA.1 variant.

In addition to this, the Sanofi/GSK booster produced twice as many neutralising antibodies against Omicron BA.1 and BA.2 when compared to the original parent virus booster.

The independent COVIBOOST study showed that, following a primary vaccination with two doses of Pfizer/BioNTech’s Comirnaty vaccine, the Sanofi/GSK booster resulted in a higher immune response than Pfizer/BioNTech’s booster or the Sanofi/GSK first-generation booster, both targeting the original D614 parent strain.

The COVIBOOST trial involved 247 participants and reported that all three vaccines provided protective antibodies against the Omicron BA.1 strain, with the highest responses coming from the Sanofi/GSK booster.

Both studies showed the Sanofi/GSK next-generation vaccine was well-tolerated, with a favourable safety profile, while in the VAT02 cohort 2 study, less than 4% of grade 3 reactions were reported, all noted as being transient and non-severe.