The European Medicines Agency’s (EMA) COVID-19 task force has decided not to recommend a fourth COVID-19 vaccine dose for the general population of the EU. The decision was made in early April in conjunction with the European Centre for Disease Prevention and Control (ECDC).

The fourth doses that were being considered are Pfizer’s Comirnaty and Moderna’s Spikevax – both mRNA COVID-19 vaccines.

However, both agencies agreed that adults aged 80 years and above can be given a fourth dose – or second booster – following data reviews. These reviews would evaluate the higher risk of severe COVID-19 in this particular age group and the protection benefits offered from a fourth dose.

Both the EMA and the ECDC stated that, at present, there is no clear evidence in the EU of a significant decrease in vaccine protection among adults aged 60 to 79 with regular immune systems.

As a result, it was concluded that there was no immediate and supporting evidence in favour of a fourth dose.

There is currently no conclusive evidence that vaccine protection against severe disease is decreasing, or that a fourth dose would make a substantial difference for those under 60 years of age with regular immune systems.

Pfizer/BioNTech have been given an expanded emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for its COVID-19 vaccine. This allows the vaccine to be given to adults aged 50 years and older as a second booster. Eligible adults can have had any authorised COVID-19 vaccine as their first booster.

A second booster dose has also been authorised for those aged 12 years and older who are immunocompromised, and have had a first booster dose of any authorised COVID-19 vaccine.

The second booster should be given at least four months after the initial booster and could potentially restore antibody levels and improve protection in older people.

The companies’ vaccine already has EUA authorisation for use as a single booster for those aged 12 and older who have already had two doses of the vaccine.
  
Those aged 18 and older could have received any approved COVID-19 vaccines for their initial two doses.

The FDA’s decision is based on data from an ongoing study of 154 healthcare workers aged 18 years and older at a single centre in Israel. The group received two booster doses during a period when Omicron was the predominant variant. No new safety concerns were recorded.

New analysis from a phase 3 double-blind, placebo-controlled trial has shown that a three-day course of Gilead’s Veklury significantly decreases the risk of hospitalisation among COVID-19 patients.

The studies revealed considerable insights into the use of Veklury (remdesivir) for the treatment of both hospitalised and non-hospitalised patients with COVID-19.
This analysis found that more than half of hospitalised COVID-19 patients were given Veklury in combination with other therapies.

A separate study, which is a new post-hoc analysis of data from the phase 3 PINETREE study, demonstrated that using Veklury within five days of symptom onset – or between five to seven days of symptom onset – reduced hospitalisations in patients at high risk for severe COVID-19 disease.

Analysis of real-world data also found that, as the pandemic progressed, the administration of Veklury within two days of hospitalisation increased from 41% to 91% between May 2020 and December 2021.

During this period, as new variants arose and disease severity fluctuated, the average hospital stay fell from seven days to six.

The research also showed that the amount of time patients needed to spend in intensive care was reduced, from 34% to 27%, with the greatest benefit emerging for the use of high-flow oxygen or non-invasive ventilation, where there was a reduction from 66% to 52%.

The Global Alliance on Vaccines and Immunisation (GAVI), MedAccess and the Open Society Foundations (OSF) have come together to help make additional COVID-19 vaccine doses available to those countries in need through a $200m agreement.

The agreement supports COVAX’s aim to make COVID-19 vaccine procurement more sustainable and better suited to the needs of specific countries. COVAX has already delivered more than 1.4 billion COVID-19 vaccines to 145 countries and territories.

“Innovative financing solutions are crucial to the success of global vaccination in 2022,” said Dr Seth Berkley, CEO of GAVI, the Vaccine Alliance. “Our partnership with MedAccess, thanks to the support of the Open Society Foundations, will allow countries to access additional resources through COVAX cost-sharing, helping them to meet the goals set out in their national vaccination strategies and respond to uncertainty and risks such as new variants.”

MedAccess CEO Michael Anderson said: “COVID-19 has wreaked havoc on health and financial systems in every country. Donors have stepped up with huge sums of money to drive COVAX’s initial dose allocations but innovative finance can unlock even greater value.
  
“Our support for GAVI will enable COVAX to work with countries to speed up access to these essential vaccines and put their programmes on a more sustainable footing.”