Covid: FDA recommends 2nd bivalent dose from 65 years old – 04/20/2023 – Health

The FDA (Food and Drug Administration), the American agency that regulates food and medicines in the United States, published last Tuesday (18) a recommendation for a new booster of the bivalent vaccine in individuals aged 65 years or older who received the first booster ( bivalent) for at least four months.

According to the agency, groups of individuals over 65 years old still represent a more vulnerable portion for serious illness, hospitalization and death, so they are eligible for a new dose of the vaccine that protects against omicron and its variants.

In addition to people aged 65 years or older, the agency also recommends that immunocompromised individuals, such as transplant recipients, people undergoing cancer treatment or carriers of autoimmune diseases, may also receive a new booster of the bivalent with an interval of at least two months from the last dose received. .

In the USA, according to data from the CDC (Center for Disease Control and Prevention), about 1,300 people still die per week from Covid, with a higher risk in older individuals or those with immunosuppression. According to FDA vaccine chief Peter Marks, Covid remains an elevated risk for many people.

On the same note, the FDA withdrew the authorization for emergency use of the monovalent forms of the Pfizer and Moderna vaccines, which were important at the beginning of the pandemic to guarantee protection against severe forms and hospitalizations due to Covid, but now, due to the new forms of the coronavirus in circulation, have a lower efficacy compared to bivalent formulations, which include the original strain from Wuhan and omicron.

With the update, individuals who have not been vaccinated or who have received a primary vaccination course (two doses or a single dose) with the monovalent vaccines can receive a bivalent booster dose. The same rule applies to children from six months of age, who can receive a schedule of two doses of the bivalent vaccine from Moderna or three doses of the bivalent Pfizer.

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understand the measure

Because it’s important

• People aged 65 years or older who have received a single dose of bivalent can receive a new booster four months after the last vaccine

• Immunosuppressed who received a single bivalent dose can receive a new booster at least two months after the last vaccine, and doses additional can be administered according to medical recommendation

• Most people ages 12 to 64 who have ever received monovalent doses may receive a single bivalent booster dose

• Individuals who are not 65 years of age or older and are not immunosuppressed on a bivalent booster dose are not eligible for a second dose

• unvaccinated people can currently receive a single bivalent dose instead of multiple monovalent doses

• Unvaccinated children aged 6 months to 5 years may receive two doses of the bivalent Moderna (6 months to 6 years) or three doses of the bivalent Pfizer (6 months to 4 years)

• In case of babies and children aged six months to 4 years deity, an extra bivalent dose will depend on the vaccine previously received

• Children aged 5 and over can receive two shots of the bivalent Moderna or a Pfizer bivalent single dose

How is it in Brazil

• In Brazil, there is only recommendation of a single dose of bivalent in people aged 60 years or older; immunosuppressed; pregnant women; population deprived of liberty and adolescents in socio-educational measures; indigenous, riverside and quilombola peoples; Health professionals; prison system officials; and people aged 12 years or older with comorbidities

• For healthy children and adolescents aged 5 to 17 years, the recommendation is primary regimen with two monovalent doses another reinforcement also monovalent

• In babies from six months old and children up to 4 years old, they are used two doses of Pfizer baby (up to 4 years) or two doses of Coronavac (children aged 3 and 4)without reinforcement

• For individuals over 18 and under 40, a primary regimen with two doses and monovalent booster with Pfizer (the ministry stopped recommending reinforcement with AstraZeneca and Janssen vaccines)

• Individuals aged 40 to 59 years without comorbidities with a complete primary regimen and a first booster can receive one more dose of monovalent booster

What are bivalent vaccines?

Bivalent vaccines are updated versions of Covid immunizers containing the original Wuhan strain combined with the omicron variant, currently prevalent worldwide.

There are two companies that have bivalent vaccines already approved for use. Moderna and Pfizer have already licensed their vaccines containing omicron subvariants BA.1 and BA.4/BA.5.

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

On January 20, Moderna filed a request with Anvisa for approval of its bivalent vaccine, but the demand is still under analysis by the agency.

Who can receive boosters with bivalent vaccines?

Despite Anvisa’s authorization for the use of bivalent boosters in all people over 12 years of age, the Ministry of Health decided to reduce the target audience of immunizations only to priority groups, which include elderly people over 60 years of age, immunosuppressed people, pregnant women and puerperal women, population deprived of liberty and adolescents in socio-educational measures, indigenous peoples, riverside communities and quilombolas, health professionals, prison system employees and people aged 12 years or older with comorbidities.

For the other Brazilians, the evaluation of the paste is that there is no proven benefit of gain in effectiveness with immunization with the bivalent booster compared to the original formulation.

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 applied?

For bivalent vaccines, a single dose is planned for all people in the priority group who received the last booster (third or fourth dose) at least three months ago.

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

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

What are the side effects of bivalent vaccines?

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

Bivalent doses have been reviewed and approved by regulatory agencies around the world, which have proven their safety and efficacy 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 boosters of monovalent vaccines and are considered mild, with symptoms disappearing within 24 hours.

Health professionals are advised at vaccination posts to monitor the intensity of the effects and, if necessary, to use common analgesic drugs 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.

What to do if I am not in the priority group to receive bivalent reinforcement?

The recommendation of experts and the health department is that, at this time, anyone who is not a priority group to receive bivalent vaccines should seek to update the booster with Pfizer’s monovalent doses.

According to the Ministry of Health, vaccination against Covid in the population over 12 years old and not included in one of the risk groups continues to be recommended with the aim of increasing coverage. In the country, until last January 5, about 69 million people had not taken the last booster dose.

Are there any contraindications for bivalent boosters?

In scientific studies, there were no side effects of bivalent vaccines different from those observed with monovalent vaccines, with a general incidence of mild effects, such as pain at the application site, fever and muscle aches.

There is also no contraindication to receiving the Covid vaccine in conjunction with other vaccines, such as the flu. Updating vaccination with boosters can be done after four months since the last vaccine applied.

Regarding the third and fourth dose boosters or for those individuals who have not yet been immunized against Covid, the Ministry of Health published on December 27th a technical note restricting viral vector vaccines (AstraZeneca and Janssen) for adults only aged over 40, with other vaccines being administered preferentially for the rest of the population.

According to the resolution, the decision is given for two main reasons: the more favorable epidemiological situation, with a large part of the population already vaccinated with the primary scheme (two doses or a single dose), and the occurrence, although rare, of adverse events serious problems related to the two vaccines, such as thrombosis with thrombocytopenia, a type of clot that can form after immunization and is associated with low blood platelet counts (or cells of the immune system).