News|Articles|April 8, 2022

ECDC and EMA Issue Advice on Fourth Doses of mRNA COVID-19 Vaccines

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

The European Centre for Disease Prevention and Control (ECDC) and the European Medicine Agency’s (EMA’s) COVID-19 task force (ETC) have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population. The vaccines being referred to are Pfizer’s Comirnaty and Moderna’s Spikevax.

ECDC and EMA concluded that there is currently no clear evidence in the European Union that adults with normal immune systems will benefit from a fourth dose. However, in adults aged 80 years and older, the agencies agreed that a fourth dose may be administered for the protection against COVID-19.

There may be a reevaluation of recommending a fourth dose for adults aged 60 to 79 years depending on the epidemiological situation changes and new data. As of now, there is no clear evidence that the current three-dose vaccination system is decreasing in effectiveness for this age group.
ECDC and EMA will continue to review available evidence on the effectiveness of COVID-19 vaccines and update their recommendations accordingly. National authorities in the EU make the final decisions on the administration of vaccines, including booster doses.

Source: EMA


Related to this article

Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation. | Image Credit: ©HockleyMedia24/peopleimages.com -stock.adobe.com
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Complying with International Pharmacopoeias
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
CPHI Milan 2026: Nitrosamine Risk Mitigation, Part 2
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.