Why did Astrazeneca withdraw the vaccine? The pharmaceutical company has gone through several stages. From the green light to the age limit, the drug against Covid has caused discussion. Especially for rare cases of thrombosis. Like the one of Camilla Canepa, the 18-year-old who died in June 2021. Recently the Genoa Prosecutor’s Office established that she could with “high probability survive” and placed five doctors from the emergency room in Lavagna, in Tigullio, under investigation, where the young woman had arrived on the evening of June 3 with symptoms of the adverse reaction to the vaccine. Camilla had been struck down by Vitt, the very rare cerebral thrombosis associated with low platelet levels and triggered by the adenoviral-based vaccine.
The EMA report
On March 18, 2021, the European Medicines Agency (EMA), after concluding its review on the presence of blood clots in people vaccinated with the Astrazeneca vaccine, confirmed the favorable relationship between the benefits and risks of the vaccine.
The cases
The blood clots identified were rare cases: around 20 million people in the UK and the European Economic Area (EEA) had received the vaccine as of 16 March that year and the EMA had looked at only 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of cerebral venous sinus thrombosis (Cvst).
The update of the leaflet
On 14 April 2021, the Pharmacovigilance Committee (PRAC) of the EMA added TTS to the information leaflet of Astrazeneca’s Vaxveria vaccine as a new possible “very rare, potentially serious” side effect, which may affect up to 1 in 10,000 people. .
Reporting of thrombosis
A few months later, in September 2021, as Facta recalls, the pharmaceutical company wrote in a press release that «cases of thrombosis with thrombocytopenia (TTS) have been reported in a small number of people. Early diagnosis allows for adequate treatment of these events and there is no increased risk of TTS at the second dose, compared to rates expected in the general population.” At a health level, therefore, Astrazeneca’s statement to the court does not represent anything new, as TTS was already listed among the rare possible adverse reactions of the vaccine.
The decision to withdraw
«Considering the quantity of available and effective vaccines for the new variants of Covid-19, there was no longer any demand for the vaccine Vaxzevria which consequently was no longer produced or distributed. Therefore, not foreseeing future demand” for the product, “AstraZeneca has therefore decided to withdraw the marketing authorization” Aic, the Anglo-Swedish company had declared to Adnkronos Salute on May 4, regarding the withdrawal of the ‘Aic in the EU entered into force on 7 May. Similar applications will also be submitted in other countries where Vaxzevria has been approved.
The side effects
Vaxzevria, a two-dose adenoviral vaccine indicated for ages 18 and over, authorized as “effective and safe”, was at the center of the news due to the risk of a rare serious complication (the European Medicines Agency EMA listed it among the effects adverse events that can occur in one case in 10 thousand) called thrombosis syndrome with thrombocytopenia or Tts. The possibility that the vaccine could, in very rare cases, be a trigger for TTS was indicated in the product information available to the public, updated in this sense in April 2021 with the approval of the English Medicines Agency MHRA.
«According to independent estimates, in the first year of use alone» of the Vaxzevria vaccine «over 6.5 million human lives were saved and over 3 billion doses were supplied globally», underlines AstraZeneca in a statement reported by the British newspaper ‘Telegraph’. “Our efforts – highlights the group – have been recognized by governments around the world and are widely considered a key component” that contributed to “ending the pandemic” of Covid. “We will now work with regulators and our partners to align on a clear path forward to conclude this chapter.”
