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Pfizer Says Final Trial Results Show Covid-19 Vaccine is 95% Effective, Ready to Seek Emergency Clearance

Vials with a sticker reading 'COVID-19/ Coronavirus vaccine/ Injection only' and a medical syringe are seen in front of a displayed Pfizer logo. (Reuters)

Vials with a sticker reading 'COVID-19/ Coronavirus vaccine/ Injection only' and a medical syringe are seen in front of a displayed Pfizer logo. (Reuters)

Pfizer said the vaccine had no serious side effects and that it will apply for emergency use authorisation from US regulators within a matter of days.

The biotech company Pfizer on Wednesday said a completed study of its experimental Covid-19 vaccine showed it is 95% effective. Pfizer said the vaccine had no serious side effects and that the company will apply for emergency use authorisation from US regulators within a matter of days.

"The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic," said Pfizer CEO Albert Bourla.

The drugmaker said efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnicity demographics, and that there were no major side effects, a sign that the immunisation could be employed broadly around the world. Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94%.

The final analysis comes just a week after initial results from the trial showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine, showing similar effectiveness.

The better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), have raised hopes for an end to a resurgent pandemic that has killed more than 1.3 million people globally and wreaked havoc upon economies and daily life.

However, while some groups such as healthcare workers will be prioritised in the United States for vaccinations this year, it will be months before large-scale rollouts begin.

Pfizer said there had been 170 cases of the disease in its trial of more 43,000 volunteers, of which 162 were observed in the placebo arm and 8 were in the vaccine group. Ten people developed severe COVID-19, one of whom received the vaccine. It also said the vaccine was well-tolerated and that side effects were mostly mild to moderate and cleared up quickly.

The only severe adverse event that affected more than 2% of those vaccinated was fatigue, which affected 3.7% of recipients after the second dose. Older adults tended to report fewer and milder solicited adverse events following vaccination.

The results come as the virus is running rampant in the US, Europe and elsewhere, placing an enormous strain on healthcare systems with record numbers of new cases and hospitalizations.

The approach of winter in the northern hemisphere in tandem with the holiday season is expected to worsen case numbers as people spend more time indoors and get together for family gatherings.

"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," said Bourla.

Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world as well as the US. They also plan to submit data from the study to a peer-reviewed scientific journal.

Pfizer reiterated it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

Pilot delivery programme in US

Pfizer has also launched a pilot delivery programme for its experimental vaccine in four US states. The vaccines must be shipped and stored at -70 degrees Celsius, significantly below the standard for vaccines of 2-8 degrees Celsius.

"We are hopeful that results from this vaccine delivery pilot will serve as the model for other US states and international governments, as they prepare to implement effective COVID-19 vaccine programs," Pfizer said in a statement on Monday.

It picked Rhode Island, Texas, New Mexico, and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunisation infrastructure, and need to reach individuals in varied urban and rural settings. The four states will not receive vaccine doses earlier than other states by virtue of the pilot, nor will they receive any differential consideration, Pfizer said.


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