Filenews 13 July 2021
Answers to FAQs on COVID vaccines-19 –
The Pharmaceutical Services of the Ministry of Health respond:
1 Why do young people need to be vaccinated?Although the individual risk of severe SARS-CoV-2 disease in young people appears to be lower than in the rest of the population, young people are not immune to the virus. They may become infected, sick and participate in the transmission of the virus. As young people remain unvaccinated, the risk of transmission of the virus increases in older people or in people in vulnerable groups - who for some reason did not receive or cannot receive the vaccine - and who are more likely to develop a serious disease and need hospitalization.
By vaccinating young people, an immunisation of a percentage of the population is achieved, which allows the immunisation of an even greater percentage required in order to achieve so-called collective immunity. That is, the limit of vaccinated individuals over which the virus will no longer find enough people to infect, which will prevent it from reproducing and spreading.
Therefore, immunization of young people with vaccination helps to contain the epidemic.
2 Why is it important to complete the vaccination regimen with both doses of vaccines?If someone receives a two-dose vaccine (Vaxzevria (AstraZeneca), Comirnaty (Pfizer/Biontech), SpikeVax (Moderna) they should complete the complete vaccination regimen with both doses to have stronger protection against COVID-19 disease.
Preliminary efficacy data from the UK showed that two doses of Vaxzevria and Comirnaty vaccines protect against hospitalizations due to the delta mutation. On the contrary, administration of only one dose appears to provide reduced protection. In a population that has received only one dose of the vaccine, there is a potential risk of virus mutations. Levels of neutralizing antibodies caused by the first dose of mRNA vaccines are low, which draws attention to the possibility of reduced protection. The longer the administration of the 2nd dose is delayed, the more likely it is that new mutations of SARS-CoV-2escaping vaccines will develop rapidly.
Therefore, the completion of the vaccination regimen with both doses is very important, so as to achieve a strengthening of the immune response and protection against new mutations.
3 Can a different vaccine be used as a 2nd dose than the one taken as a 1st dose?Vaccination campaigns in some EU Member States are known to implement a strategy of administering a 2nd dose of a different COVID-19 vaccine than that used for the 1st dose. For example, some EU citizens may receive a 1st dose with Vaxzevria, and a second dose with Comirnaty.
Such a vaccination strategy (sometimes referred to as "mix and match"), which administers a different vaccine for the 2nd dose in a recommended 2-dose program, has historically been applied to some other vaccines.
Currently, Pharmaceutical Services is unable to make definitive recommendations on the use of different COVID-19 vaccines for both doses. However, preliminary results from studies in Spain and Germany indicate a satisfactory immune response and no safety concerns. More data is expected soon, including from the COM-COV and COM-COV-2 studies, which investigate a number of vaccination regimens, which are given different vaccines for the 1st and 2nd doses. Pharmaceutical Services will continue to review the data as it becomes available.
4 What do we know so far about the possible need for a 3rd dose of vaccines (or 2nd dose for the Janssen vaccine );Based on the data available so far, we do not know the duration of protection provided by SARS-CoV-2 vaccines and whether 3rd dose (or 2nd dose for Janssen) will be needed. The duration of protection provided by vaccination is expected to be longer than natural immunity, which is acquired after natural infection (after infection of the person with the virus).
By licensing a vaccine, we only have information on the duration of protection for as long as clinical trials last. But as the manufacturer continues to monitor those vaccinated for several months or more, over time we will have a better picture of the duration of immunity. In addition, by vaccinating more people we will soon have more data to answer this question. Continuous monitoring of vaccine effectiveness is necessary as various factors, such as the virus's ability to mutate and geographical area, may affect efficacy.
Therefore, over time we will be able to better understand whether vaccines against COVID-19 disease require a booster dose or annual administration as is the case with the influenza vaccine.
5 Can COVID -19 vaccines be given to children?Although fewer children have been infected with COVID-19 compared to adults, children may become infected with SARS-CoV2, become sick and transmit the virus to other people.
At this stage, the only vaccine against COVID-19, which has been authorised by the European Medicines Agency for administration to people aged 12 years and over, is Comirnaty (Pfizer/BioNTech).
The clinical trial with Comirnaty vaccine (Pfizer/BioNTech) in children aged 12-15 years has shown that this vaccine is highly effective in preventing COVID-19disease. The most common side effects in the 12-15 age group are similar to those seen in people over 16 years of age and include injection site pain, feeling tired, headache, muscle pain and joint pain, chills and fever. These side effects are usually mild or moderate in severity and improve within a few days after vaccination.
6 Is vaccination with a vaccine not authorised by the European Medicines Agency (EMA) safe?The European Medicines Agency cannot make recommendations for vaccines that have not been evaluated for use in the European Union, as vaccines approved and administered outside the European Union are evaluated in different regulatory procedures than those of the European Medicines Agency.
Following a request by a competent body for a marketing authorisation of a vaccine in the EU, the EMA shall carry out its own independent scientific evaluation of the request to ensure the safety, efficacy and quality of the vaccine and to safeguard the confidence of citizens.
7 Do vaccines with mRNA technology affect my DNA?No. Messenger RNA (mRNA) is not the same as DNA and cannot be combined with our DNA to change our genetic code. The mRNA contained in the vaccine does not enter the nucleus of the cell where our DNA is located. It instructs our cell to produce a specific virus protein, against which our immune system then reacts and is eventually trained to react to the virus.
8 How effective COVID -19 vaccines are against delta mutation (Indian mutation) ;According to the EcDC (European Centre for Disease Prevention and Control), based on the available scientific evidence so far, the delta mutation is 40-60% more contagious than other circulating mutations in the community and is associated with a higher risk of hospitalization. It is also estimated that by the end of August 2021, it will account for 90% of all SARS-CoV-2viruses circulating in the European Union .
Preliminary scientific data indicate that the delta mutation can infect individuals who have received only one of two doses of all available vaccines. However, according to new efficacy data, taking two doses of the currently available vaccines provides high protection against hospitalization following delta mutation infection (Indian mutation) and its effects. According to the latest update from the WHO (World Health Organization), scientific studies have demonstrated the efficacy of Pfizer-BioNTech (Comirnaty) and AstraZeneca (Vaxzevria) vaccines against the Delta mutation (88% for Pfizer/BioNTech-Comirnaty and 67% for AstraZeneca-Vaxzevria).
9 Are SARS-CoV-2 coronavirus vaccines safe or have side effects? If so, what are they?SARS-CoV-2 coronavirus vaccines are safe and, based on the latest safety data, the benefits outweigh the risks. Before each approval, vaccines shall undergo rigorous testing and clinical trials to ensure that they meet internationally agreed safety and efficacy reporting standards. Competent regulatory authorities shall continuously monitor the use of COVID-19 vaccines to ensure that they remain safe.
Like all vaccines, COVID-19 vaccines can cause side effects, although not everybody gets them. The most common side effects reported for COVID-19 vaccines are mild to moderate and of short duration. The most common include redness and pain at the injection site, fever, fatigue, headache, muscle pain, chills, nausea, diarrhoea and swelling. In some cases they may be more severe or last longer. The chances of any of the above side effects after vaccination vary depending on the specific COVID-19 vaccine. More information can be found in the User's Guide Sheet, which is available for each vaccine on the website of the European Medicines Agency.
10 Why are Sputnik V and Novavax vaccines not available in Cyprus?COVID-19 vaccines may be approved and used provided that they comply with all quality, safety and efficacy requirements as set out in EU pharmaceutical legislation and after ensuring, through the scientific evaluation of the marketing authorisation application, that their overall benefits outweigh their risks.
The vaccines available in Cyprus are those that have been evaluated and licensed by the European Medicines Agency. Sputnik V and Novavax vaccines have so far not been authorised by the EMA in the EU Member States but are under rolling review. This means that the EMA evaluates the data obtained through clinical trials as soon as they become available. This process will continue until sufficient information is available to submit a formal application for marketing authorisation to the EMA.
* The answers to the above questions are based on the data available so far and on the current recommendations of European and global public health organisations and which are constantly updated.
Sources: www. cdc. gov/coronavirus, www.who.int, www. ec. europa. eu, www. ema. europa. eu
