Pfizer and BioNTech say their COVID-19 vaccine is more than 90% effective

(Reuters) – Pfizer Inc on Monday it said its experimental vaccine was more than 90% effective in preventing COVID-19 according to initial data from a large study, a major victory in the fight against a pandemic that has killed more than 1 million people, has It affected the world economy and it has changed daily. lifetime.

Pfizer and German partner BioNTech SE are the first drug manufacturers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have found no serious security issues so far and hope to apply for emergency use authorization from the United States later this month.

If authorized, the number of doses of vaccine will initially be limited. Many questions also remain, including how long the vaccine will provide protection. However, the news provides hope that other vaccines in development against the new coronavirus may also prove effective.

“Today is a great day for science and humanity,” said Albert Bourla, president and CEO of Pfizer, in a statement. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most, with infection rates setting new records, hospitals approaching overcapacity and economies struggling to reopen.”

Pfizer hopes to obtain a broad authorization for emergency use of the vaccine in the US for people ages 16 to 85. To do so, you will need to have collected two months of safety data on about half of the roughly 44,000 study participants, which is expected by the end of November.

“I’m almost ecstatic,” Bill Gruber, one of Pfizer’s leading vaccine scientists, said in an interview. “This is a great day for public health and for the potential to lift us all out of the circumstances we are in now.”

Pfizer said the interim analysis was done after 94 trial participants developed COVID-19, examining how many of them received the vaccine compared to a placebo.

The company did not break down exactly how many of those who became ill received the vaccine. Still, more than 90% effective means that no more than 8 of the 94 people who contracted COVID-19 had received the vaccine, which was given in two injections about three weeks apart.

The efficacy rate is well above the 50% effectiveness required by the US Food and Drug Administration for a coronavirus vaccine.

To confirm its efficacy rate, Pfizer said it will continue the trial until there are 164 cases of COVID-19 among the participants. Given the recent spike in infection rates in the United States, that number could be reached as early as December, Gruber said.

The data has not yet been peer-reviewed or published in a medical journal. Pfizer said it would do it once it has the results of the entire test.

Pfizer and BioNTech have a $ 1.95 billion contract with the US government to deliver 100 million doses of vaccines starting this year. They have also reached supply agreements with the European Union, the United Kingdom, Canada and Japan.

To save time, companies started making the vaccine before they knew if it would be effective. Now they hope to produce up to 50 million doses or enough vaccine to protect 25 million people this year.

Pfizer said it expects to produce up to 1.3 billion doses of the vaccine in 2021.

GLOBAL RACE

The global race for a vaccine has seen richer countries forge multi-billion dollar supply deals with drug companies like Pfizer, AstraZeneca Plc. and Johnson & Johnson Inc , raising questions about when the poorest and middle-income nations will have access to vaccines.

The US search for a vaccine has been the Trump administration’s central response to the pandemic. The United States has the highest known number of COVID-19 cases and deaths with more than 10 million infections and more than 237,000 deaths.

President Donald Trump repeatedly assured the public that his administration would likely identify a successful vaccine in time for the presidential election, which took place last Tuesday. On Saturday, Democratic rival Joe Biden was declared the winner.

Vaccines are seen as essential tools to help end the health crisis that has shuttered businesses and left millions out of work. Millions of children whose schools closed in March continue to participate in distance learning programs.

Dozens of drug manufacturers and research groups around the world have been racing to develop vaccines against COVID-19, which surpassed 50 million infections on Sunday since the new coronavirus appeared late last year in China.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which is based on synthetic genes that can be generated and manufactured in weeks, and produced at scale faster than conventional vaccines.

Modern Inc , whose vaccine candidate uses similar technology, is expected to report the results of its large-scale trial later this month. The mRNA technology is designed to trigger an immune response without using pathogens, such as real virus particles.

Pfizer alone will not have the ability to immediately provide enough vaccines for the entire United States. The Trump administration has said it will have enough supply for the 330 million US residents who want to get vaccinated by mid-2021.

The US government has said that vaccines will be provided free of charge to Americans, including the insured, the uninsured, and those who participate in government health programs like Medicare.

(Information from Michael Erman and Julie Steenhuysen; additional information from Michele Gershberg; edited by Bill Berkrot, Caroline Humer and Edwina Gibbs)