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Summary
- Several countries are reporting severe side effects and deaths after administration of Pfizer-BioNTech’s COVID-19 vaccine.
- Pfizer and BioNTech are in discussions with the Norwegian regulator for the investigation of the 29 fatalities linked to the vaccine shot.
- The Australian regulatory agency will obtain additional information from Pfizer and Norway’s regulators before the vaccine’s launch in the country.
The COVID-19 vaccine, jointly developed by Pfizer Inc (NYSE:PFE) and BioNTech SE’s (Nasdaq:BNTX), has come under the spotlight with doubts being raised concerning the vaccine’s safety profile.
The mRNA-based vaccine candidate, BNT162b2, was authorized in December 2020 by the Food and Drug Administration for Emergency Use. In late December 2020, the vaccine received the go-ahead from the European Medicines Agency (EMA).
Rising concerns over the side effects
After getting the green light from regulatory authorities, Pfizer/BioNTech’s COVID-19 vaccine doses have been secured by many countries across the world. The governments are also in discussions with the two partners for securing additional doses. However, some countries are reporting serious side effects and deaths after the administration of the first dose.
According to the Centers for Disease Control and Prevention (CDC), common side effects after administration of Pfizer-BioNTech’s COVID-19 vaccine are:
Let us look at the concerns in detail-
Norway reported 29 deaths after Pfizer/BioNTech’s COVID-19 Administration
There is rising a concern about Pfizer/BioNTech vaccine’s safety profile, especially for aged people with serious underlying health conditions in Norway. The country is in discussions with the vaccine developers after the number of deaths rose to 29.
The medical regulator of Norway said reports indicate that common adverse reactions to mRNA vaccines, including fever and nausea, might have contributed to the deadly consequence in some aged patients.
Pfizer and BioNTech are in discussion with the regulator of Norway for the investigation of deaths.
Israeli citizens suffer facial paralysis after receiving Pfizer’s COVID-19 vaccine
In Israel, a minimum of 13 people suffered mild facial paralysis after administration of the COVID-19 vaccine. Experts have raised questions whether the 2nd dose of vaccine should be administered, but the Health Ministry of Israel insists that the vaccine must be administered.
Australia seeking urgent information on Vaccine Approval
Australia has an agreement with Pfizer for almost 10 million shots of its COVID-19 vaccine., However, the country is now seeking additional critical information on the safety issues from the vaccine developers, health authorities and the government of Norway.
Reassuring Australians over the vaccine rollout of Pfizer-BioNTech’s mRNA vaccine ‘BNT162b2’, health minister Greg Hunt stated that the country is proceeding with extreme precaution.
©Kalkine Group 2021
Although the Therapeutic Goods Administration (TGA) is yet to approve the Pfizer-BioNTech vaccine, the Australia government indicated that the process should be complete by late January 2021.
The Australian health minister also added that it was unclear whether the reported deaths were related to the vaccine or because the patients were senior citizens.
Moreover, the TGA will obtain additional information from the vaccine developers and the regulators of Norway.
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