Pfizer to seek emergency use authorization for Covid vaccine with 95 percent efficacy

Published On 2020-11-19 09:00 GMT | Update On 2020-11-19 09:00 GMT

New Delhi: Pfizer Inc said on Wednesday that final results from the late-stage trial of its Covid-19 vaccine show it was 95% effective, adding it had the required two-months of safety data and would apply for emergency U.S. authorization within days.

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 immunization 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 one 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 prioritized in the United States for vaccinations this year, it will be months before large-scale rollouts begin.

Pfizer said on Wednesday 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 United States, 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," Pfizer CEO Albert Bourla said in a statement.

Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world as well as the United States. 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.

Article Source : Reuters

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Pfizer to seek emergency use authorization for Covid vaccine with 95 percent efficacy

Similar News

Boehringer Ingelheim, AnGes sign manufacturing agreement for HGF gene therapy product

Anne White to retire as Executive Vice President and President, Lilly Neuroscience

Rs 180 Crore Ozempic Fraud: LOC Issued Against Pharma Firm CEO

Revise Phase III Trial Protocol for Roflumilast Cream: CDSCO Panel Tells Sun Pharma

Illegal Alprazolam Unit Busted in Andhra, 8 Arrested, Drugs Worth Rs 24 Crore Seized

Lupin, Natco Launch Bosentan Tablets in US With 180-Day Exclusivity

Alkem Launches Olesoft Trucera Lotion to Repair Skin Barrier, Boost Hydration

US Tariffs May Pressure Indian Pharma, Threaten Biocon Revenues: Fitch