Europe edges closer to booster shots as UK agency gives nod

Europe is stepping closer to booster shots, with the UK regulator saying they’re safe while the European Medicines Agency reviews data on third jabs from Pfizer and Moderna.

A decision on the use of a Pfizer booster dose six months after the second shot is expected to come in the next few weeks, Marco Cavaleri, head of vaccines strategy at the EMA, said at a briefing.

Covid-19 vaccines made by Pfizer and AstraZeneca can be used as safe and effective booster doses, the UK’s Medicines and Healthcare Products Regulatory Agency also said on Thursday. That leaves it up to a government committee to decide whether to go ahead with such a plan.

The US, continental Europe and the UK are considering the question of boosters, even as World Health Organization Director-General Tedros Adhanom Ghebreyesus pleads for a moratorium on third shots. Tedros said on Wednesday that governments should wait at least until the end of the year so that poorer countries get better access to vaccines.

Separately, the European Union drugs regulator is preparing for a busy year-end, with decisions on a number of newer Covid-19 vaccines and antibody therapies that could help plug the gaps in supply.

The European Medicines Agency may give a green light to a vaccine from Novavax this year, with discussions expected to advance over the coming weeks, particularly on manufacturing, Cavaleri also said at the briefing on Thursday. In addition, the EMA is awaiting the submission of clinical data from CureVac NV’s shot for assessment imminently.

Discussions with China’s Sinovac Biotech on its vaccine and the developers of Russia’s Sputnik shot have also been constructive, Cavaleri said. More data needs to be submitted to progress with the reviews, he said.

While vaccines from companies including Pfizer and AstraZeneca were among the first to complete trials and receive emergency authorisations, many more shots will be needed to vaccinate the global population, particularly if booster shots are required.

“There is still overall considerable protection from severe disease and hospitalisation in the general population” from the initial vaccines, the EMA official said. “However, an increase in breakthrough infection has been reported in different parts of the world due to the delta variant” and most EU members are now discussing whether vulnerable groups would benefit from a third dose.

Cavaleri said the EMA is reviewing four monoclonal antibody products for the treatment and prevention of Covid-19 from companies such as Regeneron Pharmaceuticals, GlaxoSmithKline and Eli Lilly & Co, with decisions on potential authorisations for some expected by October. The EMA is also in discussions with other developers about submissions, including Astra, which issued positive data on its antibody combination last month.

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