AstraZeneca (AZ) has shared new data from an ongoing trial, supporting evidence that – when administered as a third dose booster – its Vaxzevria vaccine can provide an increased immune response to Beta, Delta, Alpha and Gamma SARS-CoV-2 variants.

The positive results were gathered from a preliminary analysis of an ongoing immunogenicity and safety trial.

The trial, partially double-blind, multinational, randomised and active-controlled in both previously vaccinated and unvaccinated adults, was conducted to determine the safety of the Vaxzevria vaccine.

During a separate analysis of samples from the same trial, the data also showed an increased antibody response to the highly transmissible Omicron variant.
Results from the trial involved individuals who had previously been vaccinated with either an mRNA vaccine or Vaxzevria.

In a preprinted report with The Lancet on Social Science Research Network (SSRN), a separate phase 4 trial provided data in support of a third dose of Vaxzevria for substantially increasing antibody levels following a primary vaccine series using Sinovac Biotech’s Coronavac.

So far, Vaxzevria has been granted emergency use approval and conditional marketing authorisation in more than 90 countries. It has also received an emergency use listing from the World Health Organization, allowing a rapid pathway access in up to 144 countries via the COVAX facility.

Further data analyses from the trial are expected in the first half of 2022.

In a recent announcement, BioNTech and InstaDeep unveiled the companies’ Early Warning System, a new computational method designed to analyse worldwide sequencing data and predict high-risk variants of COVID-19.

AI algorithms are combined with the structural basis of the viral spike protein to raise an alert to the presence of potential high-risk variants entered into the COVID-19 sequence data archives in less than a day. The data is based on measurements scoring fitness alongside immune escape properties.

Out of more than 70,000 recorded variants that were discovered between early October 2021 and late November 2021, Omicron has been recorded as the variant that has the highest ability to escape immunity.

Speaking on the potential capabilities of the Early Warning System, Ugur Sahin, chief executive officer and co-founder of BioNTech, said: “Early flagging of potential high-risk variants could be an effective tool to alert researchers, vaccine developers, health authorities and policymakers, thereby providing more time to respond to new variants of concern.”

BioNTech confirmed that a paper written on the new AI developments has been made available on BioRxiv – a preprint server – and has since been submitted to a peer-reviewed journal.

CEO of Pfizer, Albert Bourla, has announced that Pfizer and BioNTech have started manufacturing a hybrid vaccine to target the Omicron variant and the original COVID-19 strain.

Pfizer hopes the newly developed vaccine will offer better and more reinforced protection against the Omicron variant.

During an interview with CNBC, Bourla commented that the vaccine will also target the other COVID-19 variants in circulation.

Bourla said: “We should be in a position for regulatory approval and launch by March, [when] we will have not only data, but I think we will be ready almost to go, file and launch if it is successful.”

However, White House chief medical advisor Dr Anthony Fauci commented in December that he believed a fourth booster is not necessary, given that the already available boosters provide protection.

Data from the UK has shown that both Pfizer and Moderna’s vaccines are only around 10% effective at preventing symptomatic infection from the Omicron variant 20 weeks after receiving the second dose.

The data comes from a study by the UK Health Security Agency (UKHSA), which also found that the original two doses still provide adequate protection against severe illness.

In early January 2022, Moderna revealed that it could begin clinical trials of a specific booster jab to target the highly transmissible Omicron strain shortly, with hopes to deploy the vaccine in the autumn.

Pfizer and BioNTech have announced a new clinical study examining different regimens of the currently available Pfizer/BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will involve participants involved in the companies’ collaborative phase 3 COVID-19 booster trial.

The trial will assess the safety, effectiveness, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults aged 18 to 55 and will include up to 1,420 candidates in the three groups.

The first group received two doses of the current Pfizer/BioNTech COVID-19 vaccine 90 to 180 days prior to enrolment – in the study, participants will receive one or two doses of the Omicron-based vaccine.

The second group received three doses of the current Pfizer/BioNTech COVID-19 vaccine 90 to 180 days prior to enrolment.

In terms of real-world data, reports continue to show that individuals who are vaccinated – especially those who have received a booster shot – maintain a high level of protection against the Omicron variant, specifically for protection against severe disease and hospitalisation.

Pfizer and BioNTech have announced in joint statements that they continue to expect to produce four billion doses of their COVID-19 vaccine in 2022, even if an adapted vaccine is necessary.

Gilead Sciences has received approval of a supplemental drug application for Veklury (remdesivir) from the US Food and Drug Administration (FDA) for the treatment of non-hospitalised adult patients who are at high risk of severe COVID-19.

With the FDA’s approval, Veklury is further expanded, having been used as the antiviral standard of care for patients hospitalised with the virus. The treatment is now allowed to be administered via daily intravenous infusions over the course of three consecutive days in qualified outpatient environments.

In addition, the FDA’s expanded indication of the emergency use authorisation (EUA) for Veklury is set to include non-hospitalised paediatric patients who are 12 years of age and under who are at high risk of disease progression.

The approval follows a rapid increase in COVID-19 cases coupled with the reduced sensitivity to various anti-SARS-CoV-2 monoclonal antibodies due to the recent and highly transmissible Omicron variant.

So far, there have been no major genetic changes recorded or identified in any existing variants of concern that might significantly change the viral RNA polymerase targeted by Veklury.

The FDA’s supplemental new drug application approval and the paediatric EUA expansion have been granted alongside the recently updated National Institutes of Health (NIH) Treatment Guidelines for COVID-19 that recommend Veklury for treatment in non-hospitalised environments.