The holder of the license for the vaccine "vaxzevria", manufactured by Astra Zenek, withdrew the license for the drug in Montenegro at the end of March, and the reason for this is not doubt about the quality, safety and effectiveness of this vaccine against covid-19.
This is what the director of the Montenegrin Institute for Medicines and Medical Devices (CInMED) told "Vijesta" Snežana Mugoš.
Astra Zeneca, according to the media, recently announced that it was withdrawing its vaccine against covid-19 in the European Union (EU), and some of them linked this to the recent lawsuits by patients in the UK due to severe consequences and death after immunization, i.e. the bad reputation due to side effect among which is "Thrombosis with Thrombocytopenia Syndrome" (TTS).
However, the company announced a few days ago that the vaccine is being withdrawn from the European Union for commercial reasons and that "vaxzevria" is no longer produced or supplied, as it has been replaced by updated vaccines against new strains of covid-19.
The manufacturer's decision not to market the vaccine
Answering the questions of "Vijesti" regarding the withdrawal from circulation at the EU level, the director of CInMED Snežana Mugoša said that the holder of the license for the vaccine "vaxzevria" submitted to that institution at the end of March a request to suspend the procedure for renewing the license for the drug.
"Since, according to the Medicines Act, the license for the drug ceases to be valid after the expiration of the period for which it was issued, as the license will not be renewed, the decision on placing that vaccine on the market in the territory of Montenegro will cease to be valid," explained Mugoša.
She reminded that the holder of the license in the EU also withdrew the license for the drug on March 27 of this year and "vaxzevria" is no longer registered at the EU level.
"The last permit for the import of this vaccine in Montenegro was issued in May 2021, and taking into account the approved period of use of nine months, the vaccine cannot even be found in circulation, and therefore, there was no withdrawal of it either," she pointed out. is.
Mugoša replied to "Vijesta" that the holder of the license stated in the request to withdraw the license in Montenegro that there are no longer any commercial interests for marketing this vaccine in our country, and that for the same reasons the license was withdrawn in the EU.
"So, it is about the manufacturer's decision not to market the vaccine anymore, and not about the request of the regulatory authorities to withdraw the license, from the aspect of the existence of doubts about the quality, safety and effectiveness of the vaccine in question", she said.
Mugoša also said that the company "Astra Zeneka" has not submitted a request for a license to put another vaccine against covid-19 on the market and that they currently have no information on whether they plan to develop a new drug for this disease.
Lawsuits due to side effects in the UK
The "Oxford - Astra Zeneka" vaccine against covid was withdrawn after more than three billion doses were produced, with the company explaining that they are extremely proud of the vaccine, but that it was a commercial decision, as demand turned to new, modified vaccines against new strains of the virus . The pharmaceutical company said that according to independent estimates, more than 6,5 million lives were saved during just the first year of use of the vaccine.
"It is estimated that the 'Astra Zeneka' vaccine saved millions of lives during the pandemic, but also caused rare and sometimes fatal blood clots. In the race to get the world out of pandemic quarantine, Oxford University scientists have created a vaccine in record time. The process, which under normal circumstances would take ten years, was accelerated to ten months. In November 2020, it was announced as the 'vaccine for the world' as it was significantly cheaper and easier to store compared to other covid vaccines," the BBC recently reported.
Just a few days earlier, the BBC also reported that a class-action lawsuit had been launched in Great Britain against a pharmaceutical company over suspicions that its vaccine had caused serious illness or death. "Astra Zeneka", writes the BBC, rejects these claims, but in a court document submitted to the High Court of England in February, it admits that its vaccine against the coronavirus "can, in very rare cases, cause TTS", a syndrome characterized by the simultaneous appearance of blood clots with thrombocytopenia , that is, a low number of platelets.
Priority for the vaccine for the elderly and people with chronic diseases
During the pandemic, Montenegro acquired almost a million doses of the vaccine against covid-19, from different manufacturers, and almost half a million doses were destroyed due to the expiration date. During the last year and this year, citizens were mostly vaccinated with the Pfizer vaccine, in accordance with the recommendations of the National Immunization Advisory Committee (NITAG). That manufacturer's vaccine against covid-19 with the omikron XBB.1.5 subvariant has been approved by the European Medicines Agency (EMA) and the authorities in Montenegro.
According to current recommendations, as of January 15 of this year, the high-priority group for vaccination against covid is people older than 60, younger adults aged 18 to 59 with significant comorbidities (diabetes, diseases of the heart and other organ systems) or severe obesity , people living with HIV and transplant recipients, pregnant women, frontline health workers. They are recommended a booster dose of the vaccine at an interval of six to 12 months after the previous dose.
The medium-priority group for vaccination includes healthy adults aged 18 to 59 years and children and adolescents with comorbidities and/or marked obesity, but for whom a booster dose of the vaccine is not routinely recommended. According to the recommendations, the low-priority group for vaccination includes children and adolescents from six months to 17 years of age.
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