Published 20:22 IST, January 29th 2021
Pfizer-BioNTech coronavirus vaccine not linked to post-vaccination deaths: EU Regulator
The European Medicines Agency informed that Pfizer/BioNTech COVID jab has no link to reported post-vaccination deaths and no new side effects were identified.
The European Medicines Agency on January 29 informed that the Pfizer/BioNTech coronavirus jab has no link to reported post-vaccination deaths and no new side effects were identified. The recent data by EU’s medicines regulator comes after it was reported that dozens of mainly elderly people had died in Norway and other European countries after receiving a first shot of the vaccine. The EMA, however, quashed the report and said that it looked at the deaths and concluded that the data did not show a link to vaccination and the cases do not raise a safety concern.
In a statement, the EMA said, “Overall data is consistent with the known safety profile of the vaccine, and no new side effects were identified. The benefits of Comirnaty in preventing Covid-19 continue to outweigh any risks, and there are no recommended changes regarding the use of the vaccine”.
WHO, NMA say vaccine has ‘no direct link’
Meanwhile, apart from EMA, the World Health Organisation has also said that it sees no evidence that Pfizer and BioNTech’s COVID-19 vaccine has contributed to the deaths of the elderly people that occurred in Norway. The WHO Global Advisory Committee on Vaccine Safety said that the reports of deaths “are in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals, and the available information does not confirm a contributory role for the vaccine in the reported fatal events.” It added that the risk-benefit balance of the COVID-19 vaccine “remains favourable in the elderly”.
Initially, the deaths being reported from Norway had raised an alarm among the authorities. Just last week, it was reported that several elderly people died just shortly after receiving the first dose of Pfizer-BioNTech coronavirus vaccine in Norway. However, the health authorities in Norway had also said that "no direct link" was established between Pfizer-BioNTech's COVID-19 vaccine and post-vaccination deaths in the country.
Norwegian Medicines Agency and the National Institute of Public Health jointly assessed all reports of side effects and found that the deaths were not caused due to the vaccines but due to the health complications in the terminally ill patients, director-general of the Norwegian Institute of Public Health Camilla Stoltenberg stated in a statement. Of the deaths analysed, nine serious side effects and seven less serious side effects have been noted,” the Norwegian Medicines Agency (NMA) said. Therefore, the country recommended that the healthcare workers consider the overall health of the weak, most frail persons and comorbidities prior to administering the shot.
Updated 20:19 IST, January 29th 2021