No Urgency for Most Third COVID-19 Vaccination

Based on current evidence, there is no urgent need to administer booster (3rd) doses of vaccines to fully vaccinated individuals in the general population, announced the European Medicines Agency (EMA) on September 2, 2021.

About 33% of adults in the EU/EEA are not fully vaccinated with 2-doses.

In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course, says the EMA.

This EMA recommendation is related to a technical report issued by the European Centre for Disease Prevention and Control (ECDC).

The new ECDC report also notes that additional COVID-19 vaccine doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

'It is important to distinguish between booster doses for people with normal immune systems and additional doses for those with weakened immune systems,' says the EMA.

Some studies report that an additional vaccine dose can improve the immune response in immunocompromised individuals, such as organ transplant recipients whose low initial responses to vaccination. In such cases, the option of administering an additional dose should be considered already now.

Consideration could also be given to providing an additional dose, as a precautionary measure, to older frail individuals, in particular those living in closed settings such as residents of long-term care facilities.

Moreover, current evidence on vaccine effectiveness and duration of protection shows that all vaccines Authorized in the EU/EEA are currently highly protective against COVID-19-related hospitalization, severe disease, and death.

The current list of EMA Authorized COVID-19 vaccines is published on this webpage.

The European Medicines Agency is currently assessing data on additional doses and will consider whether updates to the product information are appropriate. EMA will also be assessing data on booster doses.

In the USA, the Food and Drug Administration amended the emergency use authorizations on August 12, 2021, for both the Comirnaty Pfizer-BioNTech COVID-19 Vaccine and the SpikeVax Moderna COVID-19 Vaccine to allow for the use of an additional dose (3rd) in certain immunocompromised individuals.

Acting U.S. FDA Commissioner Janet Woodcock, M.D., stated in a press release, “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19."

"As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time."

"The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future," concluded Dr. Woodcock's statement on August 12th.