EU: Too early to say if COVID recall is needed as Germany and France move forward

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The exterior of the European Medicines Agency can be viewed in Amsterdam, the Netherlands, December 18, 2020. REUTERS / Piroschka van de Wouw / File Photo

  • EMA and WHO say there is not enough data on boosters yet
  • Germany and France plan a 3rd dose for the most vulnerable in September
  • Some vaccine makers said boosters would be needed

BRUSSELS, Aug.6 (Reuters) – There is not enough data to recommend the use of COVID-19 vaccine boosters, the European Union’s medicines regulator said on Friday, after leading states of the EU have announced that they will deploy a third dose for the most vulnerable from September.

The European Medicines Agency (EMA) had said in mid-July that more data was needed before a recommendation on boosters could be made, but the largest EU countries, Germany and France, were prepare to deploy anyway.

This is despite a call from the World Health Organization on Wednesday to stop the boosters until more people around the world have been vaccinated. Read more

“It is currently too early to confirm if and when a booster dose for COVID-19 vaccines will be needed, as there is not yet enough data from vaccination campaigns and ongoing studies to understand how long vaccine protection will last, ”the EMA said on Friday.

Nevertheless, Germany intends to give reminders to immunocompromised patients, the very old and residents of nursing homes from September. France is also working on the deployment of third doses to the elderly and vulnerable from next month. Read more

After reports on the Berlin and Paris plans, a European Commission spokesperson said decisions on vaccinations were made by national governments, but stressed that on reminders – as well as on other matters – the EU executive encouraged “science-based decisions in accordance with EMA advice.”

In recent months, the EU has reserved billions of doses for several manufacturers of COVID-19 vaccines for years to come, saying they may be needed for recalls or to combat new variants. They could also be given to the poorest countries.

The EMA said it was working with manufacturers “to discuss plans for data generation to support the booster dosage.” Moderna (MRNA.O) and Pfizer (PFE.N) have expressed their view that the world will soon need boosters to keep immunity levels high.

WHO IS CONCERNED

WHO is also cautious about the lack of data on boosters.

“We still don’t know how, when and if a booster will be needed,” a spokesperson said at a press conference on Friday.

“There may be particular groups with particular medical conditions that may need additional doses, but at this point we are really calling, as we have been doing since the start of vaccination, to share doses where we can. “, added the spokesperson.

When asked whether the recall plans were in line with repeated EU commitments to allow equitable access to vaccines for everyone, the Commission spokesperson did not comment directly.

An internal WHO document from June viewed by Reuters shows that the UN agency viewed the use of annual boosters for the most vulnerable as the most likely scenario, but feared it would leave the poorest countries to wait. longer to have access to COVID-19 vaccines. Read more

Reporting by Francesco Guarascio @fraguarascio Additional reporting by Michael Shields in Zurich Editing by Josephine Mason and Mark Potter

Our Standards: Thomson Reuters Trust Principles.


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