The European Center for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have recommended that the use of a second booster dose of mRNA vaccines against covid-19 be considered for people aged between 60 and 79 years, and people with health conditions that cause are at high risk of a severe form of the disease.
This was announced by the Institute for Medicines and Medical Devices of Montenegro (CInMED).
"In April 2022, it was recommended that the administration of the fourth dose (that is, the second booster dose) should be considered for people aged 80 and over. However, it was also stated at that time that it might be necessary to reconsider the application of a second booster dose in persons aged 60 to 79 years, as well as persons at increased risk, in case of a change in the epidemiological situation," the CInMED press release states.
They point out that, given that a new wave of infection is currently underway in Europe, with increasing rates of people admitted to hospitals and intensive care units, it is crucial that public health authorities consider the use of a second booster dose in people aged between 60 and 79 age and person at increased risk.
"These booster doses can be taken at least four months after the previous additional dose, with a focus on people who received the previous dose more than six months ago. Given the emerging variants of the SARS-CoV-2 virus, the currently approved vaccines are still very effective in reducing the number of hospitalizations, severe forms of covid-19 and fatal outcomes.
ECDC and EMA, according to CInMED, have called on competent public health authorities across the EU to plan additional booster doses during autumn and winter for people at the highest risk of severe disease, preferably combining vaccination against COVID-19 with vaccination against influenza.
Taking into account the situation in their countries, the National Immunization Advisory Groups (NITAGs) will ultimately make decisions at the national level about which groups should receive the second booster dose.
At the end of April, NITAG recommended that the fourth dose of the vaccine against the coronavirus should be received by people over the age of 60, as well as younger people, who are at greater risk of severe forms of covid-19 infection.
At that time, they stated in the recommendations that the second booster dose is recommended at least four months after the third dose for people who received the vaccine that was given in two doses (Pfizer, Moderna, Sinofarm, Sinovak, Astra Zeneka, Sputnik V) or as the third dose for vaccines which were received in one dose (J&J vaccine).
"As the fourth dose (second booster dose) of the vaccine, mRNA vaccines are recommended - Pfizer is recommended for people under 40 years of age, and Moderna or Pfizer vaccine for people over 40 years of age," it says in earlier recommendations.
CInMED also announced that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended expanding the indication for the use of the Nuvaxovid vaccine in adolescents aged 12 to 17 years. .
"As with the older age groups, it is administered in two doses via an injection into the muscle of the upper arm, with a time gap of three weeks between doses. The main clinical trial involved more than 2200 children aged 12 to 17 years and was conducted in accordance with the Pediatric Trial Plan approved by the Pediatric Committee (PDCO) of the EMA...The CHMP considers that the use of the vaccine "Nuvaxovid in adolescents aged 12 to 17 years outweighs the risks of use," CInMED concluded. TP
At 5.000 doses given, three side effects
In Montenegro, as of July 2, a total of 675.285 doses of various vaccines against covid-19 were administered, and at the same time, health workers and patients submitted a total of 440 reports of suspected adverse events after the use of medication.
"By comparing the number of reports of suspected adverse events after immunization with the number of administered doses, it is concluded that for every 5.000 administered doses, three reports of suspected adverse events were submitted...", according to CInMED.
They point out that the largest number of applications submitted so far, a total of 231, refers to the Sputnik V vaccine, 97 to AstraZeneca, 56 to Pfizer and one to Moderna. They add that the most frequently reported adverse events after the administration of vaccines are fever, pain at the site of vaccine administration, and malaise. In addition, headache, shivering, as well as pain in muscles and joints have been reported after administration of the vaccine.
Bonus video:
