The European Medicines Agency (EMA) has issued a broad approval that allows all adults over 18 to receive a third Pfizer COVID-19 vaccination at least 6 months after the second dose of vaccine.The regulatory agency’s recommendation follows the recent similar strengthening of needle recommendations in the United States.
EMA’s recommendations are not binding, but as formal recommendations of EU countries to guide local vaccination activities. EMA’s new announcement clearly distinguishes subjects with weakened immunity from all other healthy adults.
For people with “severely weakened immune systems”, EMA strongly recommends adding a third dose to the initial vaccine regimen of Pfizer and Moderna mRNA vaccines. This dose is recommended to be given at least 28 days after the second dose.
For all other people over the age of 18, the EMA statement provided more cautious advice, focusing only on Pfizer vaccines, and concluded: “It can be considered at least 6 months after the second dose.”
“At the national level, public health agencies can issue official recommendations on the use of boosters, taking into account newly emerging effectiveness data and limited safety data,” the EMA statement read. “The risk of inflammatory heart conditions or other very rare side effects after the booster shot is unclear and is being carefully monitored. As with all medicines, EMA will continue to study all data on the safety and effectiveness of the vaccine.”
This announcement was made after months of turmoil in the United States, because different regulatory agencies and independent committees differed on how extensively the booster vaccination should be carried out. At present, the US proposal also only focuses on Pfizer’s vaccines, and recommends booster vaccination for people over 65, people with existing health conditions, or adults over 18 years of age working in high-risk occupational environments.
In response to the EMA announcement, Pfizer and BioNTech issued a statement stating that these growing announcements of enhanced needles will not disrupt any pre-existing supply agreements. The statement seems to be in response to recent criticism from the World Health Organization (WHO), claiming that the need for intensified injections is currently not supported by good evidence, and that the transfer of vaccine supplies from low-income countries will only extend the duration of the pandemic throughout the world.
“Pfizer and BioNTech continue to supply vaccines under existing supply agreements with the European Commission, including a sufficient number of boosters,” the Pfizer/BioNTech statement read. “If authorized, these companies expect that the introduction of enhanced needles in the United States and the European Union will not affect existing supply agreements reached with governments around the world and the International Health Organization.”
Several EU member states have already started bolstering programs, although most of them focus on bolstering for high-risk groups, such as the elderly or people with weakened immune systems. This new recommendation paves the way for an extensive booster vaccination program among all adults, and recommendations for other COVID-19 vaccines, such as Moderna’s vaccine candidates, are expected to be released soon.