Saturday, April 10, 2021

AFTER ASTRAZENECA, PROBLEM WITH THE JANSSEN

 Filenews 10 April 2021 - byMarilena Panagi

  


The vaccine war hasn't stopped. After the AstraZeneca vaccine, and while citizens are still reluctant to choose it for their vaccination, yesterday there were more than 10,000 doses unclaimed, under the microscope of the European Medicines Agency (EMA), there are now also cases of thrombosis that have also been recorded in recent times and this time concerning the fourth vaccine licensed, that of Janssen (also known as Johnson&Johnson), which although approved has not yet been distributed to the Member States of the European Union.

At European level, in the countries that have made age restrictions on the administration of the AstraZeneca vaccine, Greece has also been added, which has decided that it will not administer this formulation to citizens under 30 years of age.

At national level, the Ministry of Health did not make any announcement on this either yesterday, and there has been no formal notification or intention to diversify Cyprus' vaccination programme. Behind the scenes, of course, dialogue and exchange of views are under way between Cypriot scientists, but they have not yet been made public.

The embarrassment of the competent authorities, of course, is undeniable, since every day the reluctance of Cypriot citizens to respond to the call for vaccination is becoming more and more pronounced. The problems of the vaccination programme have now been added to the technical issues arising in the electronic appointment settlement platform, as the citizens' attempt to book one of the available vaccines from companies other than AstraZeneca is constantly putting the system at risk of collapse.

It is no coincidence, after all, that yesterday information was leaked to the press concerning the consultations of the Ministry of Health with manufacturers on the supply of 100,000 doses of the Sputnik V vaccine, when it is authorised by the European Medicines Agency. In particular, according to the Cyprus News Agency, the consultations are at a very advanced stage and concern the purchase of 50,000 doses of the Russian vaccine, with the right to purchase another 50,000 doses, on the basis of a decision taken by the Council of Ministers in early March.

In relation to the vaccine, the European Medicines Agency has begun rolling a rolling review of Sputnik V (Gam-COVID-Vac), developed by Russia's Gamaleya National Centre for Epidemiology and Microbiology.

Yesterday, the Vaccination Portal was opened at 8 a.m. with 15,020 appointments available. By 3 p.m., only about 4,500 appointments had been arranged, of which 3230 were for Phizer vaccines and only 1,200 for AstraZeneca vaccines, so that for the third consecutive time, the "gateway" would be put into operation without a meaningful response from citizens for vaccination. Yesterday the number of beneficiaries, based on the age group that had the right to arrange appointments, was around 25,000 citizens.

Indeed, if what has happened over the last several weeks around the AstraZeneca vaccine is repeated in the next period and for the Janssen vaccine, the reluctance of citizens may become even more widespread, with the result that the vaccination programme in Cyprus and the other EU Member States is in total danger of collapse.

In relation to the new EMA investigation, the Agency's competent Committee announced yesterday that it had 'initiated a safety signal assessment of reports of thromboembolic events (formation of blood clots, resulting in blockage of a vessel) in persons receiving COVID-19 Vaccine Janssen'.

According to the notice, 'four serious cases of abnormal blood clots with low platelets have been reported following vaccination with Janssen's COVID-19 vaccine', while 'one incident occurred in a clinical trial and three cases occurred when the vaccine was available in the US. One of them was fatal," he notes. 'From these safety-signal reports, it is currently not clear whether there is a causal link between vaccination with covid-19 Janssen vaccine and these conditions. The PRAC Committee is investigating these cases and will decide whether regulatory action may be required, which usually consists of updating product information. The EMA will communicate further once the evaluation has been completed."

It is reported that this vaccine is currently only used in the US, with an emergency license. The COVID-19 Janssen vaccine was approved in the EU on 11 March 2021. The vaccine has not yet been made available in any EU Member State, but is expected in the coming weeks.

WHO does not approve a second dose with another vaccine

WHO does not approve the administration of a second dose of vaccine with other vaccines to people who have already received the first dose of AstraZeneca vaccine, the World Medicines Agency, which was asked to place itself, following the decision of some states, such as France, to follow this tactic in groups of their population.

"There is not the right data to say whether this is something that can be done" and therefore agency experts concluded "that switching vaccines is not something they can recommend at this stage," Margaret Harris, a WHO spokeswoman, said during the regular briefing of journalists in Geneva. The spokeswoman recalled that this is the position adopted by the WHO Expert Advisory Group (SAGE) on vaccination in February, before reports of a possible link between this vaccine and very rare cases of thrombosis.

571 people were vaccinated in their homes

Normally the process of home vaccination involving bedridden people continues and is ongoing throughout Cyprus. According to a statement from the Ministry of Health, "one of its main objectives is the vaccination of vulnerable groups of the population, which has already been achieved since after the completion of vaccination of nursing home tenants, we have vaccinated 80% of people over 80 years of age, and we are at an advanced stage to complete the first dose of vaccination of patients who are bedridden and at home. So far, 571 people have been vaccinated."

The whole effort "began on 3 March 2021 and the interest expressed exceeded all expectations. For the whole effort we had 12 mobile units with 23 specialized nurses of Community Nursing of the public/OKY, covering urban and rural areas of Cyprus".

Patients who are registered as bedridden as registered in the General Health System Information System (medical profile of a beneficiary) were entitled to apply for home vaccinations, in accordance with the definition in force under the General Health System.