ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines

EMABased on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

Evidence on vaccine effectiveness and duration of protection shows that all vaccines authorised in the EU/EEA are currently highly protective against COVID-19-related hospitalisation, severe disease and death, while about one out of three adults in the EU/EEA over 18 years is still currently not fully vaccinated. In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course. To complement vaccination efforts, it is also crucial to continue applying measures such as physical distancing, hand and respiratory hygiene, and using face masks where needed, in particular in high-risk settings such as long-term care facilities or hospital wards with patients at risk of severe COVID-19.

It is important to distinguish between booster doses for people with normal immune systems and additional doses for those with weakened immune systems. Some studies report that an additional vaccine dose can improve the immune response in immunocompromised individuals, such as organ transplant recipients whose initial responses to vaccination were low. 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.

The European Medicines Agency (EMA) 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.

While EMA assesses relevant data, Member States may consider preparatory plans for administering boosters and additional doses.

Advice on how vaccinations should be given remains the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State. These bodies are best placed to take into account the local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capacities of national health systems.

The ECDC will update its technical report as ECDC and EMA continue to work together to collect and assess data that are becoming available on boosters and additional doses. Close monitoring of vaccine effectiveness data and breakthrough infections, particularly among vulnerable groups at risk of severe COVID-19 and among those living in closed settings, should be continued. In the meantime, Member States need to prepare for possible adaptations to their vaccination programmes should a substantial decrease in vaccine effectiveness be noted in one or more population groups.

The technical report issued by the European Centre for Disease Prevention and Control (ECDC):
Interim public health considerations for the provision of additional COVID-19 vaccine doses

Most Popular Now

SK bioscience and GSK start Phase 3 trial of adjuv…

SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination wit...

No serious health effects linked to mRNA COVID-19 …

Federal and Kaiser Permanente researchers combing the health records of 6.2 million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 v...

Blood vessels produce growth factor that promotes …

Blood vessels supply tumors with nutrients and, on the other hand, enable cancer cells to spread throughout the body. The settlement of circulating tumor cells in a dista...

First-in-human clinical trial for a vaccine to tre…

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by resear...

Sandoz strengthens pipeline by entering into agree…

Sandoz, a Novartis division, today announced that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706). B...

Pfizer and BioNTech submit a variation to EMA with…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Condition...

A drug costing less than €2 a day helps in the tre…

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. This is the finding of a study by investigators at th...

Rheumatoid arthritis treated with implanted cells …

With a goal of developing rheumatoid arthritis therapies with minimal side effects, researchers at Washington University School of Medicine in St. Louis have genetically ...

NIH scientists build a cellular blueprint of multi…

Chronic lesions with inflamed rims, or "smoldering" plaques, in the brains of people with multiple sclerosis (MS) have been linked to more aggressive and disabling forms ...

Scientific evidence to date on COVID-19 vaccine ef…

An expert review by an international group of scientists, including some at the WHO and FDA, concludes that, even for the delta variant, vaccine efficacy against severe C...

How a plant virus could protect and save your lung…

Using a virus that grows in black-eyed pea plants, nanoengineers at the University of California San Diego developed a new treatment that could keep metastatic cancers at...

COVID-19 nasal vaccine candidate effective at prev…

Breathe in, breathe out. That’s how easy it is for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. And though remarkable progress has been made in develop...