Pfizer and Moderna vaccines against Covid-19: Omicron approved by European Medicines Agency

In a statement, the European Medicines Agency (EMA) said both vaccines target the Omicron BA.1 subtype in addition to the original strain of the coronavirus.

The European medicines regulator on Thursday approved the first vaccines against Covid-19 to be adapted from Pfizer/BioEntech and Moderna’s Omicron variant, aimed at a recall campaign this winter to prevent new waves.

The European Medicines Agency (EMA) in Amsterdam has approved “vaccines targeting the Omicron BA.1 subtype in addition to the original strain” of the coronavirus that originated in the Chinese city of Wuhan in 2019. They are made for people 12 years and older who have received at least one primary vaccination against Covid-19. These vaccines are adapted versions of the original vaccines Comirnaty from Pfizer/BioEntech and Spikevax from Moderna. However, they do not target the infectious BA.4 and BA.5 sequences of the Omicron variant, which have emerged as the world’s dominant strains in recent months. The EMA recently said it aims to get approval “before the fall” of Covid vaccines targeting these two subtypes.

“Other suitable vaccines covering different types, such as the Omicron BA.4 and BA.5 subtypes, are under consideration by the EMA or will soon be submitted and, if approved, will further expand the arsenal of available vaccines,” the EMA said on Thursday. Vaccines targeting the Omicron variant are eagerly awaited by European countries so booster campaigns can be launched before a feared resurgence of Covid-19 cases this winter.

“Today’s positive comments from the European Medicines Agency on the first two variant matched mRNA vaccines from BioNTech-Pfizer and Moderna are important to protect Europeans from the risk of autumn and winter infections,” European Health Commissioner Stella Kyriakites said in a statement. “We have to prepare for another winter with Covid-19,” he added. US health officials on Wednesday approved a new version of vaccines against Covid-19 from Pfizer and Moderna.

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“Mild Side Effects”

EU member states are still using the same coronavirus vaccines approved two years ago for use against the original strain of the virus. They offer some protection against Omicron and its subtypes, which are less harmful but more infectious than the original strain, but fear a new wave this winter as the world waits for more targeted and effective vaccines. Omicron and its subtypes dominated throughout 2022, quickly replacing the earlier Alpha and Delta types. The BA.4 and BA.5 subvariants have caused a wave of new cases in Europe and the US in recent months.

All Omicron types have a mild disease course because they settle less in the lungs and more in the upper nasal passages, causing symptoms such as fever, fatigue, and loss of smell. The EMA said the review of the adapted Pfizer and Moderna vaccines will focus on data from laboratory studies and tests on the immune response against the original strain and the Omicron variant. “Side effects seen with the adapted vaccines are comparable to the original vaccines and are generally mild and short-lived,” the agency said.

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