Bulgaria offers third jabs against Covid-19 for certain categories

Bulgaria has begun offering third doses of vaccines against Covid-19, a week after an expert council recommended guidelines regarding who may receive them.

The doses are being offered at various hospitals, medical centres, immunisation centres at regional health inspectorates and by general practitioners, Bulgaria’s Health Ministry said on September 28.

The ministry said that as of 11am on September 28, a total of 126 third doses of vaccines against Covid-19 had been administered.

So far, third doses have been administered in the districts of Sofia, Bourgas, Plovdiv, Varna, Pleven, Vratsa, Kyustendil, Shoumen and Yambol, the statement said.

The expert advisory board issued its guidelines on September 23.

Those who may request a third dose include immunocompromised persons – people with primary and secondary (eg HIV-AIDS) immune deficiencies, people with cancer, transplant patients on immunosuppressive therapy, people being haemodialyzed; as well as patients on cytostatic or corticosteroid therapy.

Also on the list are people in senior citizens’ and social care homes, medical staff who have a high risk of infection, and people older than 65.

The list also includes those who have not developed sufficient immunity after vaccination (missing specific antibodies or immune cells against new coronavirus) one month after the completion of the vaccination cycle.

There are a number of recommended conditions for administering the third dose.

These include that the person has undergone a full vaccination cycle and is not contraindicated for the next dose.

Before administering an additional dose, a clinical examination and assessment of the person’s condition should be performed by a general practitioner or specialist treating the person.

If someone who has not developed sufficient immunity after vaccination has a negative result from an immune response test, an assessment of the immune status should be made to rule out primary or secondary immune deficiency, according to the guidelines.

The guidelines say that there should be a test for specific antibodies or immune cells after completion of a vaccination cycle before administering an additional dose.

The expert council proposed that the additional or booster dose should be the Pfizer- BionTech mRNA vaccine, due to an application to the European Medicines Agency by the manufacturer for approval of the additional dose, the expert council said.

The expert council recommended that the booster dose should be given no earlier than six months after the completion of the vaccination cycle, while it recommended that the interval be eight months in the case of people in senior citizens’ homes, medical staff and the over-65s.

The statement said that in individuals who have not developed sufficient immunity after vaccination – those with primary or secondary immune deficiencies and those with no specific antibodies or immune cells against new coronavirus – the recommended interval for additional dosing is one month after the completion of the vaccination cycle.

In the days since the expert council’s recommended guidelines were published, no specific order on the matter has been issued by caretaker Health Minister Stoicho Katsarov.

Separately, Bulgaria’s Military Medical Academy said on September 27 that on that day, 60 people, including 27 medical staff and 33 members of the public, had received a third dose against Covid-19.

Vaccination was being carried out in line with the recommendations of the expert advisory council, the Military Medical Academy said.

The head of the academy, Ventsislav Mutafchiyski, received a third dose last week, “setting a personal example, as he did at the end of last year, when he was among the first vaccinated in the country,” the statement said.

At this stage, revaccination (booster dose) with mRNA vaccine (Comirnaty or Spikevax) is allowed only in people who had completed the vaccination course, regardless of the type and the name of the vaccine administered against Covid-19, the Military Medical Academy said.

The booster dose will be given at least 180 days after the second dose of the two-dose vaccines and the first single dose of the single-dose vaccines, it said. The booster dose will be given at this stage only to people 18 years of age and older, the academy said.

St Anna Hospital in Sofia said that it was offering third doses. The hospital’s vaccination centre is open from 8am to 8pm every day including weekends. No pre-registration is required.

The Health Ministry said that as of September 28, booster doses are available at Alexandrovska Hospital in Sofia. Opening hours are from 8am to 5pm on weekdays. Only those meeting the criteria set by the expert advisory council may receive a booster dose, the statement said.

On September 27, the European Medicines Agency (EMA) said that it had started evaluating an application for the use of a booster dose of Spikevax (Moderna’s Covid-19 vaccine) to be given at least six months after the second dose in people aged 12 years and older.

Booster doses are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection after it has waned, the EMA said.

EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Spikevax (Moderna), including results from an ongoing clinical trial. 

Based on this review, the CHMP will recommend whether updates to the product information are appropriate. EMA will communicate the outcome of the assessment in due course. 

While this evaluation is ongoing, EMA and the European Centre for Disease Prevention and Control (ECDC) have highlighted their position regarding the need for additional and booster doses of Covid-19 vaccines in a separate communication.

“Although EMA and ECDC do not consider the need for Covid-19 vaccine booster doses to be urgent in the general population, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary,” the agency said.

It said that advice on how vaccinations should be given remains the prerogative of the national immunisation technical advisory groups guiding the vaccination campaigns in each EU member state.

“While EMA assesses relevant data, member states may already consider preparatory plans for giving boosters and additional doses,” the EMA said.

(Photo: Military Medical Academy)

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