Contents
The Committee for Medicines for Human (CHMP) of the European Medicines Agency (EMA) recommended on September 1 the approval of two vaccines targeting the Omikron BA.1 sub-option in addition to the original SARS-CoV-2 strain. These are preparations by BioNTech / Pfizer and Moderna. Health Minister Adam Niedzielski announced that vaccines will soon be available in Poland.
- Bivalent vaccines, i.e. vaccines developed on the basis of the original SARS-CoV-2 virus and the Omikron variant, developed by Pfizer and Moderna, have been approved by the European Medicines Agency
- Now the consent to use vaccines has to be issued by the European Commission
- Earlier, new vaccines were approved by the US Food and Drug Administration
- Both companies started working on a vaccine against Omikron at the beginning of the year
- Omicron is the most contagious variant of the coronavirus to date. His subsequent sub-options have caused several serious contamination waves this year
- More information can be found on the Onet homepage
The EMA recommends new vaccines
Comirnaty Original / Omicron BA.1 and Spikevax Bivalent Original / Omicron BA.1 are intended for use in people 12 years of age and older who have received at least the primary COVID-19 vaccination.
As highlighted by the EMA in the published release, vaccines are being modified to more effectively counter circulating SARS-CoV-2 variants.
«Studies have shown that Comirnaty Original / Omicron BA.1 and Spikevax Bivalent Original / Omicron BA.1 can elicit a strong immune response against Omikron BA.1 and the original SARS-CoV-2 strain in previously vaccinated individuals. In particular, they were more effective in eliciting immune responses against the BA.1 sub-variant than the original vaccines. The side effects seen with the adapted vaccines were comparable to those seen with the original vaccines and were usually mild and of a short duration. Both CHMP opinions will now be sent to the European Commission, which will take a final decision, »the EMA informed.
Niedzielski: vaccines will soon be in Poland
The decision of the Committee for Medicinal Products for Human Use was also announced by the Minister of Health, Adam Niedzielski. As he announced, the preparations will soon be available in Poland.
These vaccines are versions of the primary vaccines Comirnata (Pfizer / BioNTech) and Spikevax (Moderna) that target the omicron BA.1 sub-variant, in addition to the original SARS-CoV-2 strain.
“Today the EMA decided to vaccinate people from the age of 12 with a second booster dose of preparations targeting the omicron mutation. @EU_Commission will approve the decision today or tomorrow. Vaccines soon in PL »- wrote Niedzielski on Twitter.
Grzegorz Cessak, President of the Office for Registration of Medicinal Products, also informed about the EMA’s decision.
The head of the URPL indicated in his information that vaccines adapted, i.e. updated to better match the circulating SARS-CoV-2 variants – are an important tool for pandemic control as the virus evolves.
He reported that studies have shown that Comirnaty Original / Omicron BA.1 and Spikevax Bivalent Original / Omicron BA.1 can elicit a strong immune response against the omicron BA.1 variant and wild-type SARS-CoV-2 virus in previously vaccinated subjects. In particular, they were more effective in triggering immune responses against the BA.1 subvariant than wild virus vaccines.
The side effects he reported with the adapted vaccines were similar to those he reported with the primary vaccines and were generally mild and of a short duration.
We are waiting for the decision of the European Commission
Both opinions of the Committee for Medicinal Products for Human Use (CHMP) will be sent to the European Commission for a final decision.
The head of URPL pointed out that as the pandemic unfolds, the EU’s strategy is to have a wide range of adapted vaccines that target different variants of SARS-CoV-2 so that Member States have ample opportunities to meet their needs when developing a vaccination program. This is a key component of an overall pandemic control strategy as it is not possible to predict how the virus will develop or what variants will occur this winter.
He indicated that other adapted vaccines containing different variants, such as the Omicron BA.4 and BA.5 sub-variants, are currently under review by EMA or will be submitted shortly and, if approved, will further expand the vaccine arsenal available.
The President of URPL noted that the wild virus vaccines Comirnaty and Spikevax are still effective in preventing severe diseases, hospitalization and deaths related to COVID-19 and will continue to be used as part of the vaccination campaign in the EU, in particular for primary immunization.
He recalled that it would be up to the national authorities in EU Member States to determine who and when should receive the appropriate type of vaccine, taking into account factors such as infection and hospitalization rates, risk to vulnerable populations, vaccination coverage and vaccine availability.
FDA approved earlier
On August 31, updated vaccines from Moderna and Pfizer companies, directed against the Omikron variant, were approved by the American Food and Drug Administration (FDA). The new preparations are to replace those used so far in booster doses.
Have you been infected with COVID-19? Be sure to check your health. The Healing Blood Test Pack, available on Medonet Market, can help you with this. You can also make them at home.
The approved formulations are bivalent vaccines containing components of both the primary coronavirus strain and the Omikron variant. In principle, they are also supposed to protect against the sub-variant of Omikron BA.5.
The preparations are to reach pharmacies and doctors’ offices in early September and replace those used in booster doses at least two months after the first series of injections. Moderny vaccine has been authorized for use in people from 18 years of age, and Pfizer – from 12 years of age.
The US has so far ordered a total of 171 million doses of vaccines from both companies.