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Pfizer-BioNTech Covid-19 vaccine is 95% effective: US drug regulator confirms

Pfizer/BioNTech Covid-19 vaccine is 95% effective, US regulators have confirmed.

The Food and Drug Administration (FDA) said it found no safety concerns to stop the vaccine from receiving emergency approval.

The agency is yet to approve the vaccine, but has published a document stating the trial data was “consistent” with the recommendations set out in its emergency use guidance.




The FDA will meet on Thursday to make a formal decision.

Meanwhile, UK has already started using the Pfizer/BioNTech Covid-19 vaccine for mass use after an approval last week.

The in depth material, published by the FDA, shows the vaccine is 95% effective against Covid-19, in keeping with the headlines published by the pharmaceutical company Pfizer.



Although two doses are needed to offer full protection, the first jab prevented 89% of the most severe cases.

And the vaccine gave similar levels of protection to people who had already had a Covid infection.

It added that the most common side effect experienced by people who received the vaccine was pain, redness or swelling at the injection site (generally the arm).

That was followed by short-term fatigue, headache and muscle-pain.

But beyond these mild effects, there was no notable difference in health conditions between the vaccinated and control groups during the study period.

Pregnant women and under-16s were not included in the studied, and so the vaccine will not yet be approved for these groups.

UK and US regulators have slightly different approval procedures for new vaccines.

Both complete an internal assessment and consult an advisory board, but the FDA also looks at raw figures as well as trial write ups.




Using these raw figures it has come to more or less the same conclusion as the pharmaceutical company.

If the vaccine is authorised in the US, it will continue to be monitored for safety.