Pfizer CEO Albert Bourla has announced plans to submit an application of data to the US Food and Drug Administration (FDA) highlighting the need for a fourth dose of the company’s COVID-19 vaccine.

In January, Pfizer/BioNTech began a study to evaluate the safety of an Omicron-based vaccine candidate in healthy adults aged 18 to 55.

Trial data published in February from an Israeli study demonstrated that a fourth vaccination might potentially raise antibody levels but offers little extra protection beyond a third dose.

In the UK, there has recently been a sharp rise in infection rates and hospitalisations due to the virus. Looking at mortality rates for COVID-19, a new study published in The Lancet, involving research funded by the Bill & Melinda Gates Foundation, found that although reported COVID-19 deaths between January 2020 and December 2021 had officially hit approximately 6 million worldwide, the real total may be closer to 18 million deaths over that time frame.

According to the study, India was found to have the highest number of excess deaths – compared to the number of deaths that would be expected on the basis of past trends in all-cause mortality – followed by the US and Russia.

The researchers noted: ‘Strengthening death registration systems around the world, long understood to be crucial to global public health strategy, is necessary for improved monitoring of this pandemic and future pandemics.’

The US Food and Drug Administration (FDA) will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in April.

The meeting is to discuss requirements for future COVID-19 vaccine boosters and the process for selecting specific strains of coronavirus for COVID-19 vaccines to address current and new, emerging variants.

Representatives from the National Institutes of Health and the US Centers for Disease Control and Prevention will take part in the meeting, along with the independent experts of the advisory committee.

The committee will review the need to update the current COVID-19 vaccines to address specific variants, and consider the requirements for future COVID-19 vaccine booster shots.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward.”

The FDA said in a statement that no vote is planned at the meeting and there will not be any opportunity for discussion of any product-specific applications.

Moderna has asked the US Food and Drug Administration (FDA) to amend its emergency use authorisation (EUA) so that its COVID-19 vaccine, Spikevax, can be given as a second booster shot to adults 18 years and over.

On 31 January 2022, the US FDA approved a Biologics License Application for Spikevax for adults 18 years of age and older. Previously, the vaccine had been available under emergency use authorisation in the US from 18 December 2020.

The US Centers for Disease Control and Prevention (CDC) and healthcare providers want to establish the benefits of a second booster for all adults. This includes those who are vulnerable and are placed at a higher risk of COVID-19 because of their age or comorbidities.

Dr Julian Tang, a virologist and respiratory medicine specialist at the University of Leicester in the UK, said: “Ideally, we need new COVID-19 vaccines designed specifically against Omicron if we want to improve this protection for the most vulnerable.”

Moderna has stated that its submission is partially based on recently published data produced in the US and Israel, following the emergence of Omicron. In addition to this, the company said that it continues to monitor real-world data for its vaccine and has ongoing clinical trials for its Omicron-specific booster and a bivalent Omicron-specific booster.

Alphabet’s Verily Life Science has signed a new contract with UK biotech Oncimmune to investigate autoantibodies found in people who have developed long-lasting symptoms, known as ‘long COVID’, after contracting COVID-19.

The project will analyse potential patterns of autoantibodies, which are antibodies that react with self-antigens. These are often present in COVID-19 in the early stages of the infection and are associated with the development of long COVID.

Studies have shown that some COVID-19 patients experience notable increases in autoantibody reactivities, including some which appear to target immune components like chemokines, cytokines and complement proteins.

Although this area of research is still relatively new, scientific developments have shown that autoantibody activation occurs more often after an asymptomatic COVID-19 infection in women and a symptomatic infection in men.

By using Oncimmune’s infectious disease panel of biomarkers to find autoantibodies that are indicators of long COVID, researchers are able to see if levels are the same in long COVID patients during their recovery.

Verily has been involved in the COVID-19 response since the beginning of the pandemic, using some of its laboratories to test and develop screening tools for hospitals and healthcare systems, while working with Janssen to understand the impact COVID-19 can have on patients’ immune systems immediately after receiving positive test results.