With 95% Success, Pfizer To Seek Emergency Approval For COVID-19 Vaccine Use

Pfizer Inc is ready to apply for emergency approval of its COVID-19 vaccine candidate from the US FDA in the next few days.

The decision follows the optimistic results from the late-stage trial of the vaccine, which turned out to be 95% effective among people of all ages.

Pfizer Covid-19 vaccine candidate (Image: Reuters)

The American pharmaceutical major confirmed that it had the required two-months of safety data to apply for emergency US authorization. Pfizer Inc also said that it has conducted trials on people across ages and ethnicities and that the effectiveness of the vaccine has been found to be consistent with no major side effects. This means that the vaccine, once developed, can be used for immunising people across the world.

The new numbers are mentioned in a final analysis that comes after a week of the initial results from the trial that showed the vaccine to be more than 90% effective. As per the final readings, efficacy of the vaccine in adults over 65 years, an age group that is particularly susceptible to the virus, was over 94%.

The final results

The vaccine candidate, developed in partnership with BioNTech, showed better than anticipated results in its trials. As per Pfizer, a total of 170 cases of the COVID-19 disease emerged in its trial of more 43,000 volunteers. Out of these 170, 162 were observed in the placebo arm and 8 were in the vaccine group.

A report by Reuters quoting the company explains that ten people developed severe COVID-19, only one of whom received the vaccine.

Side effects from the vaccine candidate have been reported to be mild to moderate and very short-lived, as the vaccine is being considered well-tolerated among the test subjects. A 3.7% of recipients experienced fatigue after the second dose of the vaccine. Older adults had even milder side effects following the vaccination.

"With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world," Pfizer CEO Albert Bourla said in a statement.

Though true, a large-scale rollout of the vaccine is not expected for the next few months. This is because the initial doses of the vaccine will be administered to the healthcare workers in the US post production. Pfizer still expects to make around 50 million vaccine doses this year, enough for 25 million people.

Pfizer Covid-19 vaccine candidate (Image: Reuters)

In addition to the United States, Pfizer and BioNTech now plan to submit the data to other regulatory agencies around the world. They also plan to submit the study observations to a peer-reviewed scientific journal.

Other drugmakers are also in pursuit of the right vaccine against the novel disease. Moderna Inc, on Monday, released preliminary data for its vaccine, showing similar effectiveness as Pfizer¡¯s candidate. Both the vaccines are based on messenger RNA (mRNA).