Covid vaccine: FDA authorizes version against variants – 09/11/2023 – Health

The FDA (Food and Drug Administration), the American agency responsible for approving medicines and vaccines in use in the United States, approved this Monday (11) the request for emergency registration of Moderna and Pfizer’s Covid vaccines formulated for the variants in circulation.

According to the agency, the new formulas contain fragments of genetic material from the XBB.1.5 subvariant of the omicron, discovered at the end of the year and which was considered highly transmissible by the WHO (World Health Organization).

The agency analyzed studies that prove the safety and effectiveness of the formula, as well as pre-clinical trials in which a high response was observed from the updated vaccine against the EG.5 and BA.2.86 variants, which have seen an increase in cases in several countries in the months July and August.

According to the note published on its official page, the American agency stated that, based on all the evidence, the risk and benefit analysis of the new vaccines considered that the vaccine is effective, safe and can be administered to people aged six months or older of age who have already had a complete primary course of monovalent Covid vaccines.

Still according to the agency, although serious cases of Covid are rarer in children and young people, these can occur, and vaccines significantly reduce the risk of having serious consequences from Covid.

In Brazil, Anvisa has not yet presented the record of vaccines updated with the variants in circulation. According to the agency, both Pfizer (Cominarty) and Moderna (Spikevax) have already filed a request to register vaccines updated with XBB.1.5, and these are under analysis.

The bivalent vaccines from Pfizer and Moderna, formulated with the ancestral Wuhan strain and the ômicron, continue to be authorized for use, although only the bivalent Pfizer has been distributed by the federal government.

Individuals aged 12 or over, for whom vaccine registration is definitive, and those aged six months to 11 years old, in which case the agency has approved the emergency use of Covid vaccines, can be vaccinated in the USA with the updated formulas. .

With the publication of the note, the bivalent vaccines previously approved by the agency are no longer authorized for use in the United States.

Because it’s important

• People aged five years and over, regardless of previous vaccination, can receive a new booster with the updated vaccine two months after the last vaccine

• Babies and children aged 6 months to 4 years previously vaccinated can receive one or two doses of the updated vaccine (time and number of doses administered depend on the Covid vaccine they received before)

• Infants and children aged six months to four years who have never received monovalent doses can receive up to three doses of Pfizer’s updated formula or two doses of Moderna’s new version

• The agency remains confident in security It is efficiency and an analysis of the risk versus benefit of vaccines shows that they remain beneficial for all individuals six months of age or older

• Individuals who receive the new updated version may feel the same Side effects already described for vaccines Covid mRNAsuch as pain at the injection site, redness, muscle pain, and headache

• The updated versions of the vaccines should offer good protection against Covid and the variants in circulation, but the agency understands that in the face of a new, more virulent strain, transmission is likely to only be reduced with an annual update of the vaccines, as is done for the influenza virus each year

• Manufacturers Pfizer and Moderna estimate that the new formulas should be available for use next fall in the United States (spring in Brazil) and that updated versions with other variants in circulation should be made available in the future

What is it like in Brazil

• In Brazil, there is only a recommendation for a single dose of bivalent in all people aged 18 or over;

• Anvisa approved the use for adolescents aged 12 to 17 bivalentbut the Health Ministry has not yet expanded the recommendation for this age group;

• For healthy children and adolescents aged 5 to 11 years, the recommendation is primary regimen with two monovalent doses another reinforcement also monovalent;

• In babies from six months of age and children up to 4 years old, two doses of Pfizer baby (up to 4 years old) plus a monovalent reinforcement or two doses of Coronavac (children aged 3 and 4) also with monovalent reinforcement.

What are updated vaccines?

The updated vaccines against Covid contain the XBB.1.5 subvariant of omicron, considered highly transmissible by the WHO.

Updated versions with the EG.5 and BA.2.86 sublineages, considered a variant of concern by the WHO, are expected in the future.

There are two companies that have updated vaccines already approved for use. Moderna and Pfizer have already licensed their vaccines containing the ômicron subvariant XBB.1.5.

In Brazil, Anvisa (National Health Surveillance Agency) approved the emergency use of two bivalent formulations from Pfizer (for BA.1 and BA.4/BA.5). The agency authorized the use of vaccines as boosters for people aged 12 and over.

On June 26, Anvisa also authorized Moderna’s bivalent vaccine, Spikevax, but it is not yet available nationwide.

Who can receive boosters with bivalent vaccines?

In Brazil, currently, all people over 18 years of age can receive a booster with the bivalent vaccine. The Health Ministry should also soon expand the recommendation for adolescents aged 12 to 17.

In the case of children aged 5 to 11 years, the recommendation is that a booster be given with Pfizer’s single-void formula.

It is worth noting that all Covid vaccines continue to be considered safe and protect against hospitalizations and deaths.

How many booster doses will be given?

For bivalent vaccines, a single dose is expected to be administered to all people who received the last booster (third or fourth dose) at least three months ago.

There is still no plan in Brazil for the inclusion of bivalent vaccines as a form of primary regimen against Covid — that is, in people who have never received a dose against Covid.

At the end of January, Anvisa received the request for definitive registration of Pfizer’s bivalent vaccines. In the case of definitive authorization, the vaccine can also be used outside the health emergency scenario against Covid. All other vaccines currently used in the country, except Coronavac, already have definitive registration.

What are the side effects of bivalent vaccines?

In general, updated vaccines against omicron maintain the same safety standard as the monovalent forms already authorized and used in billions of people around the world.

The bivalent doses were analyzed and approved by regulatory agencies around the world, which proved their safety and effectiveness as a vaccine booster.

In general, the most common effects that have been reported are pain at the injection site, fatigue, headache, body aches (myalgia), fever and chills.

Such effects have also been reported with monovalent vaccine boosters and are considered mild, with symptoms disappearing within 24 hours.

The guidance of health professionals at vaccination stations is to monitor the intensity of the effects and, if necessary, the use of common analgesic medications for treatment.

Other less common side effects considered moderate to severe may include myocarditis (inflammation of the myocardium), pericarditis (inflammation of the pericardium), chest pain, shortness of breath and arrhythmia.