Wednesday, September 1, 2021

THIRD DOSE OF VACCINE WITH THE LEGAL SERVICE

 Filenews 1 September 2021 - by Marilena Panagi



The Legal Service will "pass" the vaccination of citizens with a booster dose, in order to eliminate any concern about the legal consequences that the Republic of Cyprus may suffer, from the beginning of the new vaccination program, without the official recommendation of the competent European Medicines Agency (EMA). The question to the Legal Service, of course, will not concern whether or not a third dose of vaccine should be administered to specific groups of the population, since this must be taken for granted, but when the Republic of Cyprus will be able to start repeat vaccination and whether it would be more appropriate to prepare a consent form to be signed by citizens before their vaccination (in case the program starts to be implemented prior to the recommendation by the EMA).

The legal issues that may arise from the occurrence of side effects from the administration of a third dose, in case the vaccination is done before the official establishment of the EMA, were also addressed in yesterday's meeting of the Minister of Health with the scientists and officials of the competent departments of his ministry. As reported by "F", the competent officials insisted on the view that, regardless of whether the majority of EU Member States have already taken their relevant decisions, Cyprus should wait (for good evil), for the official recommendation of the EMA, with an alternative proposal of course, the setting of a date for the start of repeated vaccination at a later stage (as other states have done), pending communications from the competent European Body or the application of the 'consent form', as was also the application of the 'consent form', as was also the subject of the initial vaccination of elderly people in nursing homes.

On the substance of the issue and regardless of the time of the start of the new vaccination program that will be addressed, for the time being to specific groups of the population, scientists and the Minister of Health, they decided that:

► The third dose will be given to all persons over 65 years of age.

► All immunocompromised/transplanted individuals and people with serious chronic diseases regardless of age.

► Vaccinations will start from nursing homes.

► The possibility of booster vaccination also remains open to health professionals.

► The procedure to be followed has not been finalised, although according to information provided by "F", appointments will be arranged automatically and depending on the date of the second instalment to each citizen.

► The third dose will be given to all persons in these categories six months after receiving the second dose of the vaccine.

► An exception will be specific groups of immunosuppressed individuals, who will receive the booster dose in a much shorter period of time than the second dose, since, as international studies suggest, people with immunosuppression either lose their immunity very quickly, or do not develop any antibodies at all after their vaccination.

The scientists' proposal, as well as the practice followed by most states that have decided to boost their population, concerns the administration of mRNA vaccines as a third dose, regardless of whether a person has been vaccinated with a vaccine of another technology previously.

In practice, however, things are a little clearer since in Cyprus, those people who had received mRNA technology vaccines (Pfizer and Moderna) have completed six months after their full vaccination. Citizens who had been vaccinated with AstraZeneca vaccines have not yet completed six months from receiving the second dose.

As far as the J&J vaccine is concerned, which is monododosic, Cyprus will probably follow the practice of many states with the mix&match tactic, which is considered safe and based on this, these citizens, if they wish to receive a booster dose, will be vaccinated with a vaccine of Moderna or Pfizer, unless of course newer ones emerge from the manufacturing company itself.

What was decided at yesterday's meeting is expected to be put before the Council of Ministers for approval on Thursday, the day on which it will probably be determined and after the relevant opinion has been given by the Legal Service, the date of the start of the repeat vaccinations.

Stella Kyriakides: "We have to be ready"

The European Union must be ready for the third dose, European Commissioner, Stella Kyriakides, said in a statement, announcing at the same time that at EU level the target of fully vaccinating 70% of the population before the end of the summer has been achieved. "Today we can feel proud that our European Vaccination Strategy has paid off, achieving the target we set in January, of 70% of fully vaccinated citizens by the end of the summer," she said, adding that "this is an important milestone in our efforts to end the pandemic and its impact on societies and economies but mainly on the human lives that are being lost. From the selection and joint pre-purchase of safe and effective vaccines, to the immediate organization and implementation of national vaccination strategies by member countries, we have ensured the fastest possible availability of vaccines to our citizens."

"The new mutations make it a necessary condition to exceed 70% in order to be safe", explains Stella Kyriakides, stressing that "we must be one step ahead of the virus. At the same time, we urgently need to address the gap in vaccination rates among our Member States and be ready to make available boost doses if scientific evidence suggests that this is the way to deal with the disease."

The decisions of states at EU level and internationally

► France: The decision to grant a third dose was taken at the beginning of July and provided for the start of vaccinations in mid-September. It concerns citizens over the age of 65, immunosuppressed people and patients with serious chronic diseases. The third dose will be administered six months after receiving the second dose of the vaccine.

► Austria: The country intends to proceed with the administration of the third dose in two phases and the start of vaccinations is due in mid-October. The first phase will involve closed facilities, nursing homes and people with serious chronic diseases. In a second phase, a booster dose will be administered to all citizens who complete the 9th month after receiving the second dose.

► Hungary: The decision to administer a third dose was taken a few weeks ago and concerns all those who complete 4 months after receiving the 1st dose of the vaccine. The choice of the vaccine will be made by the citizen himself.

► Belgium: It was decided to administer a third dose to immunosuppressed individuals.

► Germany: The booster dose is for the elderly and the severely chronic.

► Ireland: A third dose is intended to be given in the autumn to people over 80 years of age, health professionals and people with chronic conditions. In a second phase it will be administered to all people 60-80 years of age.

► Lithuania: The relevant decision provide for the administration of a booster dose to immunosuppressed individuals in the first phase and in the second phase during the winter months in the general population.

► Malta: The third dose will start to be administered in mid-September to immunosuppressed people and residents of nursing homes.

► Slovenia: Booster dose will be administered to immunosuppressed/transplanted individuals and chronic patients four months after receiving the second dose.

► Luxembourg: According to the relevant decision, the third dose in the first phase will concern only immunosuppressed individuals.

► Sweden: The third tranche will start in the autumn to people in high-risk groups with provision for the programme to be extended to the general population at the beginning of 2022.

► Decisions are pending in Greece, the Czech Republic, Finland, Italy, Bulgaria, Croatia, Denmark and Estonia.

In the rest of the world:

► Israel: The third dose was initially administered to people over 60 years of age but has now been extended to all citizens aged 12 and over. It is already given within 5 months of the second dose. The relevant program in the country is at an advanced stage and the support dose has been received by more than two million citizens.

► United Kingdom: The third dose is expected to start in September and will initially involve immunosuppressed people, health professionals and people over 70 years of age. In a second phase, members of the families of immunocompromised individuals and all people 50 years of age and older will be included in the program.

► USA: The third dose is administered to all persons over the age of 18 who have been vaccinated with the Pfizer and Moderna vaccines.