European Vaccine Authorization Withdrawn From AstraZeneca Amid Safety Concerns
The move follows the FDA revoking Johnson & Johnson emergency authorization in 2023 over similar clotting concerns.
Pharmaceutical giant AstraZeneca requested that the European authorization for its COVID-19 vaccine, Vaxzevria, be withdrawn, according to the European Medicines Agency (EMA). The EMA stated that the approval for AstraZeneca's vaccine had been pulled “at the request of the marketing authorization holder.”
AstraZeneca’s COVID-19 vaccine was first approved by the EMA in January 2021. However, concerns about the vaccine’s safety quickly emerged when dozens of countries suspended its use after unusual but rare blood clots were detected in a small number of immunized people. These side effects led vaccine safety advocates to give covid vaccines the nickname “clot shots.”
The EU regulator had originally concluded that AstraZeneca’s shot did not raise the overall risk of clots...likely resulting in numerous deaths.
A study published in The New England Journal of Medicine analyzed the first 220 cases of blood clotting complications associated with the Oxford-AstraZeneca vaccine in the United Kingdom. The study reported a mortality rate of 22% for the vaccine-induced immune thrombocytopenia and thrombosis (VITT) condition. The researchers also found that 41% of VITT patients had no underlying health issues diagnosed.
What Is Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT)?
Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) is a rare blood clotting disorder associated with the AstraZeneca and Johnson & Johnson COVID-19 vaccines. The condition is characterized by low platelet counts and blood clots, predominantly in the cerebral venous sinuses, but also in other parts of the body.
VITT was first identified in March 2021, when several European countries suspended the use of AstraZeneca’s vaccine due to concerns about its safety.
The exact cause of VITT is not yet fully understood, but it is thought to be related to an immune response triggered by the vaccine. This response leads to the production of antibodies that target platelets, causing them to clump together and form blood clots. The condition is similar to heparin-induced thrombocytopenia, which is a rare complication of treatment with the blood thinner heparin.
The incidence of VITT is low, with an estimated risk of 1 in 100,000 to 1 in 250,000 vaccinations. However, due to the severity of the condition and the potential for severe complications or death, it has raised concerns about the safety of the AstraZeneca and Johnson & Johnson vaccines.
Both AstraZeneca and Johnson & Johnson (J&J) Vaccines Are Adenovirus Vector (DNA) Vaccines
The AstraZeneca and Johnson & Johnson (J&J) vaccines are adenovirus vector vaccines, which use a modified virus to deliver a piece of genetic material (DNA) from the SARS-CoV-2 virus into human cells. This genetic material instructs the cells to produce the spike protein found on the surface of the SARS-CoV-2 virus.
The immune system recognizes the spike protein as foreign, mounts an immune response, and produces antibodies and immune cells that would ostensible recognize and fight off the actual virus if the person is later exposed to it.
The spike protein now produced by the human cells in response to the vaccine may have toxic effects, as suggested by some research. Both mRNA and DNA/viral vector vaccines force the body to create spike protein in human cells, just through different mechanisms. Because cells needed by the body are producing a foreign spike protein and then being attacked by the immune system, the likelihood of an autoimmune reaction seems somewhat high.
Johnson & Johnson COVID-19 Vaccine Pulled by FDA in June 2023
The FDA revoked the emergency use authorization of Johnson & Johnson’s COVID-19 vaccine in June 2023, in part due to a formal request from Janssen Biotech, the vaccine’s manufacturer. The FDA had originally restricted J&J’s vaccine to special use due to the blood clot risk in May 2022. The decision to completely pull J&J was made after approximately 12.5 million doses had expired, leading to a significant decline in demand.
Initially approved in early 2021, the Johnson & Johnson vaccine quickly encountered challenges, including reports of severe blood clotting disorders including Thrombosis with Thrombocytopenia Syndrome (TTS) in some recipients.
Additionally, manufacturing issues at a Baltimore facility, which included a contamination incident that resulted in the disposal of 60 million doses, severely undermined public confidence in J&J.
AstraZeneca Sent to Poor Countries Despite Manufacturing Mistake
While Johnson & Johnson dealt with contamination issues at their manufaturing facility, AstraZeneca had its own manufacturing sanfu, which impacted its first major trial.
This manufacturing mistake led to initial concerns about the vaccine’s efficacy in older populations. Thus, many countries initially restricted the vaccine’s use to younger populations before reversing course, potentially further compounding the clotting risk, as it may be in part a function of the stronger immune systems found in younger people.
Epidemiological data has shown varying patterns, with some reports suggesting slightly higher instances of VITT among younger adults compared to older adults. This observation might be influenced by multiple factors, including the broader immune response variability among younger populations or possibly differing exposure to the vaccine types by age group due to vaccine rollout policies.
But despite clotting concerns, billions of doses of the AstraZeneca vaccine were distributed to poorer countries through a U.N.-coordinated program, as it was cheaper and easier to produce and distribute than other vaccines on the market.
The United Kingdom’s national coronavirus immunization program heavily relied on AstraZeneca’s vaccine in 2021, but later resorted to purchasing mRNA vaccines for its covid booster vaccination programs. As of now, the AstraZeneca vaccine is rarely used globally.
This withdrawal of European authorization for AstraZeneca's COVID-19 vaccine raises questions about whether a similiar shoe will eventually drop for mRNA vaccines.
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In this case, “better late than never”, DOES NOT APPLY. Prison is the only answer to all these jackals.