Approval of the CureVac, Sputnik and Novavax vaccines at the European Medicines Agency
Dr Borut Štrukelj from the Faculty of Pharmacy in Ljubljana and President of Headmasters' Association Gregor Pečan participated at today’s press conference on the current situation regarding the Covid-19 disease.
On Sunday, 1842 PCR tests were carried out, 290 of which were positive. The positivity rate is 15.7 per cent. There were 205 positive tests last Sunday, one-third fewer than yesterday. A total of 6491 rapid antigen tests were also carried out. Today, 494 people are in hospital (473 yesterday, 458 on Saturday), of whom 94 are in intensive care. There were 4 deaths. At the end of the week, 82 patients were admitted to hospital due to COVID-19, 43 on Sunday and 39 on Saturday. A total of 37 patients were discharged at the end of the week. On Sunday, 18 patients were discharged, and 19 on Saturday. There are 10,635 active (known) COVID cases in the country, and today, the seven-day rolling average of daily positive tests is 825 (yesterday 808, Saturday 802).
The vaccination campaign against COVID-19 is being promoted under the single graphic image with the slogan “Good habits are contagious – let's get vaccinated.” An independent website, www.cepimose.si, has been established, intended for both the general and the professional public. The website covers current news, presents a vaccination plan and provides timely information on the number of vaccinations performed and the implementation of vaccination, vaccines supplied, vaccination centres and side effects. The most frequently asked questions are addressed by experts, and special sections are dedicated to information on vaccines, vaccine performance and health advice, and publication of the results of the pandemic exhaustion study. In accordance with individual phases of vaccine promotion, information on specific aspects of the organisation and implementation of vaccination will also be provided.
Three vaccines under “rolling review” at the EMA
There are 23 vaccines in the third phase of clinical trials, and the European Medicines Agency (EMA) is conducting rolling reviews for three vaccines. The first is CureVac vaccine, which is based on mRNA technology, the final approval for which is expected in just over a month. The Sputnik V vaccine, which is a classic vector vaccine, is not yet close to approval as an extensive part of the documentation for the third phase of study is missing, as few individual tests have been performed. Some EU countries and non-EU countries are opting for the Sputnik vaccine but it would not be sensible for EU members to decide independently of the EMA. The third vaccine is Novavax, which is a protein-based vaccine made using biotechnology and is therefore different from mRNA and vector vaccines. The vaccine is 90% effective.
Among the recommendations of vaccination experts, Štrukelj first stressed the EMA’s decision regarding the safety of the AstraZeneca vaccine, which is safe and effective. It achieves basic effectiveness in preventing more serious illness, but it does not reach such a level of ideality that it would protect a person from infection.
Regarding the incidence of blood clots, these are considered to occur very rarely as a result of vaccination, namely one case per million vaccinations. By comparison, the occurrence of blood clots when taking oral contraceptives can be seen in 1,000 cases per million. With regard to vaccination certificates, the group proposes that, in addition to basic information, they should also contain information on the immune system response to vaccination. Regarding the clarification on vaccine content, as many call centres as possible should be set up, following the example of a government call centre, which would play a major role. This could also relieve the pressure on treating physicians and general practitioners. The Novartis plant in Mengeš has the space and human resources to produce vaccines but the legislation concerning the manufacture of pharmaceutical products is very strict so the types of production cannot be easily changed.
Performance of distance learning, NAK, competitions and high school enrolment
The assessment of the results of distance learning is not black and white. Knowledge is worse than would be with achieved with live lessons, but the picture is not so black that we can talk about a “lost generation” said Pečan. Testing and vaccination are being carried out regularly according to plan. There should be as much information about vaccination as possible to dispel doubts, which are useful if they are based on fact. Dealing with conspiracy theories is not constructive.
In the past week, 1.5 per cent of employees tested positive. There are more than 100 departments in quarantine across the country. Children’s motor abilities have decreased, and a broader social incentive for children and parents to be as active as possible would make sense.
Regarding the National Assessment of Knowledge (NAK), reform is needed and tests should be given some content or concrete meaning. In this situation, when distance learning lasted for several months, schools need the peace, time and energy to make up as much as possible for what was lost, so it is a waste of time to implement NAKs. Today’s implementation of NAK’s brings anticipated problems, such as the fact that their use is not supported on all browsers.
Various competitions are also held, the results of which are important in awarding scholarships. The conditions for students are difficult and not equally fair to all. Therefore, school principals have called for the competitions not to be held this year.
The enrolment system for secondary schools should be changed. Instead of the system based on grades awarded in some subjects in the final triad of primary school, entrance examinations should be introduced, which would, for example, apply to 45 secondary schools for the last year.