EMA will authorize third dose for seniors. Portugal just waits the green light
The scientific evidence available so far is that the vaccine scheme is effective, but it is starting to become clear that this protection, despite being explicitly, is not as high after a few months as after vaccination in the above age groups 65 years old. In this sense, taking into account the results of two large scientific studies and the experience of some countries, which started the third dose, everything indicates that the administration of this dose has a reduced risk and a previous positive impact on people. “It was in this way that the source linked to the vaccination process explained to the DN what should be followed in relation to the vaccine booster for a senior age group.
According to her, this is also the interpretation that must be accepted by the experts of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which is expected to reach a decision in early October, probably as early as next week, without permission for the vaccination booster to be allowed for people over 65 years of age. “In light of the scientific evidence, everything points out that the EMA’s decision goes in this direction,” said the same source.
Therefore, when the Prime Minister, António Costa, addressed the country this Thursday to announce that conditions were met to move forward to the third and final phase of the prolonged discontinuation that began in July and that everything was ready to move forward. with the third dose at the age of 65, I knew this was the understanding of the experts of the Technical Commission on Vaccination (CTV) against Covid-19.
Portugal is just waiting for the green light from the EMA to move forward, since “”we live in a European space and we must wait for the authorization of the EMA, until vaccines are made available for this purpose”, they explained to the DN. However, there are EU member states that they have already decided to administer this booster dose, even without a decision from the European health authority, although “they face higher legal risks, without a formal decision from the EMA”, argued the DN sources.
But, last Thursday, António Costa guaranteed that the country has enough doses of vaccines to start this new campaign against covid-19, hoping that it will be finished by Christmas, so that we will all see this season “protected more “
Remember that Portugal has already reached 83% of the vaccinated population, taking advantage of six percentage points of the total population that can be inoculated (89%) -11% are under 12 years old. But Portugal is also one of the countries that, since the beginning of September, can vaccinate with the third dose all people over 16 with immunosuppression. The recommendation was made by the Directorate General of Health (DGS) on September 1, after advice from the CTV, and the European Centers for Disease Control (ECDC) to consider that it should be recommended “for people with severely weakened immune systems , as part of your primary vaccination.
The DGS norm includes people transplanted (less than three months ago), with HIV / AIDS, patients with active cancer disease, Down syndrome and other autoimmune diseases. A recommendation that is already being followed by other countries outside the European space, namely the USA, which, this week, also authorized the vaccination booster for people over 65 years of age. White House epidemiologist adviser Anthony Fauci had said last Sunday in an interview that a third dose for the elderly was inevitable and that the Biden administration was keen to do so.
The European Union awaits the green light from the EMA, which, since 6 September, and as announced, is evaluating the data produced by Pfizer / BioNTech on the results in relation to the studies carried out on a booster dose for people like over 65 years, given six months after the second dose.
There is still no evidence for a third dose in the youngest
The discussion of the third dose of the covid-19 vaccine will not stop here, even after this decision by the EMA. For DN sources, this vaccine booster must continue to be monitored. Not least because the question is already being raised in relation to the population in general, but, according to Portuguese experts, “there is still no information available on this subject. In other words, in relation to the elderly, we know that there is a reduction in protection that it ends up translating into an increase in risk for the disease, but for younger groups this is not so evident”.
Therefore, they underlined, “the issue must continue to be monitored, even in relation to other risk groups. In a while, it may be concluded that the adult population should also receive the third dose“, yielding:” Vaccines were high to protect us in relation to serious and very serious disease and, in this respect, have already proven their effectiveness. Just look at what is happening in Portuguese homes, where some outbreaks are being registered, but with a reduced number of deaths and with mild infections or even without symptoms. “
The same sources point out that, in relation to age groups under 65, this assessment must take into account the reality of each country. “Even within the European space, the realities are different. There are countries that have a higher vaccination coverage than others and there are countries that have a much older population than others, such as Portugal. And, for now, it is this that must be protected, “they maintain. Remember that ECDC, in an opinion issued earlier this month, admitted “there is no urgent need” to administer booster doses to absolutely vaccinated in the general population.
The EMA’s decision regarding the third dose should be known as early as next week. The Pfizer / BioNTech vaccine was the first to be analyzed, but, according to a statement from the EU, Moderna’s laboratory will also present its results to the EMA.
The European Union has signed three agreements with Pfizer / BioNTech for the purchase of 2.4 billion doses, with the agreement providing for the availability of around 900 million vaccines, which means that a part will be used in boosters, in case these will be considered included or if new variants of the virus emerge. At present, 70% of the EU population has been fully vaccinated. A very different situation is experienced by other countries on continents such as Africa, Asia and Latin America. For this reason, a World Health Organization (WHO) came to the request to the richest countries to delay this reinforcement in favor of the vaccination campaign for the most needy countries.