Deadly AstraZeneca fails US certification
Anglo-Swedish vaccine maker AstraZeneca announced that it will
no longer pursue emergency approval for its Wuhan coronavirus
(COVID-19) vaccine in the United States.
Early on in the pandemic, the manufacturer applied for an emergency
use authorization (EUA) with the U.S. Food and Drug Administration
(FDA). However, the regulator refused to authorize the shot after its
clinical trials showed a lack of elderly people. Of the 660
vaccinated participants older than 65 in the clinical trials, only two
people caught COVID-19.
In addition, concerns about blood clots caused by the AstraZeneca
COVID-19 vaccine was a huge factor for the FDA's refusal to sign
off on it. The resulting stalemate, which lasted for more than
a year, came to an end on Nov. 10 as the vaccine maker abandoned
efforts to get an EUA due to its "over-complicated" application.
"As the primary vaccination needs of the U.S. are being met already,
AstraZeneca has decided that it will not submit a biologics license
application for Vaxzevria," said CEO Pascal Soriot. Vaxzevria is
the shot's brand name in Europe. It is sold under the name CoviShield
in other parts of the world.
Soriot added: "The company will continue to focus its efforts in
ensuring availability of Vaxzevria elsewhere around the world,
including submissions for its use as a booster."
While the FDA did not grant approval to Vaxzevria, other regulators
- such as the European Union's European Medicines Agency and
Australia's Therapeutic Goods Administration - permitted the
vaccine's use in their respective jurisdictions.
AstraZeneca made use of a weakened adenovirus - the pathogen
responsible for the common cold - to deliver the SARS-CoV-2 spike
protein and train cells to recognize it. The messenger RNA (mRNA)
vaccines from Pfizer and Moderna, meanwhile, make use of mRNA
inside lipid nanoparticles to deliver the spike protein in the body.
Moreover, AstraZeneca's vaccine was priced cheaper at around $3
per dose - compared to the mRNA shots priced at around $19 each.