Coronavirus: AstraZeneca removes Vaxzevria vaccine from the market due to commercial reasons
The British pharmaceutical giant AstraZeneca withdrew its Covid-19 vaccine Vaxzevria from the market on Wednesday for commercial reasons, one of the first to be marketed during the pandemic. In an interview with PÚBLICO, infectious disease specialist and former Secretary of State for Health Promotion Margarida Tavares argued that this is a commercial decision, “which in no way diminishes the value of this vaccine.” In Portugal, according to Infarmed, no stock of these vaccines has been available since the end of June 2022.
“Since multiple vaccines against Covid-19 have been developed, there is a surplus of updated vaccines” for the different virus variants, “resulting in decreased demand”, the pharmaceutical company explained in a statement.
The announcement that the vaccine would no longer be sold starting this Wednesday had been made earlier in the week by the pharmaceutical company.
The National Authority for Medicines and Health Products – Infarmed, in a written response to PÚBLICO, confirmed that on March 27, the European Commission accepted “a request to revoke the Marketing Authorisation submitted by the holder company AstraZeneca“.
By the end of April, the European Medicines Agency (EMA) recommended updating Covid-19 vaccines for the 2024/2025 vaccination campaign to protect against the new variant of the SARS-CoV-2 virus, JN.1. “JN.1 differs from the XBB family targeted by previous updated vaccines and has now surpassed the XBB variants to become the most widely circulating variant worldwide,” the pharmaceutical company emphasized.
Companies currently developing new Covid-19 vaccines that do not target JN.1 were also encouraged to contact the EMA to discuss strategies for altering the composition of their vaccines.
“Since the vaccine has not been prescribed, the pharmaceutical company understood, and it is likely very acceptable understanding, that it would not be worthwhile to update the vaccine for this new variant given that, regardless of this update or not, it is not being significantly prescribed to maintain production,” elaborated Margarida Tavares.
In February 2021, Portugal advised against administering the AstraZeneca vaccine to individuals over 65 years of age. A few months later, in April, the Directorate-General of Health (DGS) would only recommend it to individuals over 60 years old. This decision came after the European Medicines Agency acknowledged a link between this vaccine and rare cases of thromboembolism associated with a sharp drop in platelets. It was out of “precaution” that Portuguese health authorities decided to suspend immunizing the younger population with this vaccine.
Despite this course of action, Margarida Tavares emphasizes the importance that the Vaxzevria Covid-19 vaccine had: “The past is very important. AstraZeneca was one of the first – and that is very important – to be able to protect people against Covid-19 and had very high efficacy and effectiveness.”
Rare side effects
Asked about reports of side effects associated with this vaccine, the former State Secretary highlights the safety that has always been demonstrated by the drug in various studies. “What led to the vaccine being passed over are very rare effects,” namely, cases of thromboembolism associated with a sharp drop in platelets.
Referring to existing scientific studies and the EMA’s own reports, Margarida Tavares notes that the available data shows that by May 2023, there were around 900 cases of thrombosis syndromes associated with low platelets. “And of these 900, it reduces to 200 the cases associated with a fatal outcome. This is very low compared to the vast number of people vaccinated.”
Therefore, the epidemiologist from São João Hospital in Porto believes that the quick development of Covid-19 vaccines brought “some insecurity and fear”, which are, however, “completely unfounded.” “Vaccines are highly safe and effective and protect people from severe illness, hospitalization, and death,” she concludes.
Infarmed also emphasizes that “these events cannot be considered related to the Covid-19 vaccine just because they were spontaneously reported to the National Pharmacovigilance System“. According to this drug authority, as of this Tuesday, the total number of reported adverse reactions to drugs (ADR) related to this vaccine was 9852. “Therefore, the number of ADR cases per 1000 doses administered correspond to an incidence of 4.4 ADR cases per 1000 doses administered“, states the drug authority.
According to the data sent to PÚBLICO, of these nearly ten thousand reports of adverse reactions to the vaccine, the severity criterion assigned to the case at the time of reporting, by the reporter, is distributed as follows: 32 cases of death; 94 life-threatening cases; 218 hospitalizations; 443 disability cases; 1089 clinically important cases; and 7976 non-severe cases.
“In the vast majority of reported cases where there is information on medical history and concomitant medication, a fatal adverse outcome can be explained by the patient’s medical history and/or other treatments, with diverse causes of death and no uniform pattern. Covid-19 vaccination does not reduce deaths caused by other causes, health problems unrelated to vaccine administration, so it is expected that deaths from other causes will continue to occur during vaccination campaigns, sometimes closely associated with vaccination, and without necessarily having any relation to vaccination“, highlights Infarmed.
News updated at 7:52 p.m. on May 8, 2024 with information collected from Infarmed
