EU drug regulator gives nod to Pfizer COVID vaccine booster for people aged 18 and older

On Monday, booster doses of the Pfizer-BioNTech COVID-19 vaccine for people aged 18 and above received nod from the European Union's drug regulator. The European Medicines Agency (EMA) stated that booster doses for patients aged 18 and older should be considered at least 6 months following the second dose, reported The Associated Press (AP). The regulator further stated that persons with extremely impaired immune systems should receive a third dose of either the Pfizer-BioNTech or the Moderna vaccine at least 28 days after their second shot. The recommendation comes after researchers found that an extra dose of these vaccines boosted the ability of organ transplant patients with weaker immune systems to develop antibodies against the virus that causes COVID-19. Notably, the recommendations will be forwarded to health authorities in each of the EU's 27 member states. However, booster shots have already begun to be administered in several nations, reported AP. 

Although there is no direct evidence that these patients' ability to develop antibodies protected them from COVID-19, the increased dose is predicted to improve protection in some patients. However, the agency will continue to monitor any new information about its effectiveness, according to a report by EMA. The report further stated that it's critical to understand the difference between an extra dose for persons with impaired immune systems and booster doses for people with healthy immune systems. The EMA's human medicines committee (CHMP) reviewed data for Comirnaty that showed an increase in antibody levels when a booster dosage was administered around 6 months after the second dose in patients aged between 18 to 55. Based on this information, the committee decided that booster doses for those aged 18 and above should be considered at least six months following the second dose. 

'EMA will continue to examine all data on the vaccine's safety and effectiveness'

According to the EMA report, public health agencies at the national level may offer official recommendations on the use of booster dosages, based on developing effectiveness data and inadequate safety data. After a booster, the risk of inflammatory heart diseases or other extremely rare side effects is unknown and is being closely watched. As with other medications, the EMA will continue to examine all data on the vaccine's safety and effectiveness, the report stated.  National immunisation technical advisory groups (NITAGs), which guide vaccination campaigns in each EU Member State, continue to be in charge of their implementation across the EU. These bodies are ideally positioned to consider local factors, such as the propagation of the virus, particularly any potentially dangerous strains, vaccine availability, and national health system capacities. The report also stated that the EMA will continue to collaborate closely with national authorities and the European Centre for Disease Prevention and Control (ECDC) to assess existing data and provide recommendations to protect the public during the ongoing coronavirus pandemic. 

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