Pfizer: Covid-19 Shot 95% Effective, Seeking Clearance Soon

A view of Pfizer Manufacturing Belgium in Puurs, Belgium, on Nov. 9, 2020. (AP Photo/Virginia Mayo)

(CN) — After millions of Covid infections and 250,000 deaths in the United States — the most in the world — pharmaceutical giant Pfizer on Wednesday announced a viable vaccine candidate is 95% effective and on the path to quick federal approval. 

Pfizer and German biotechnology company BioNTech announced the vaccine candidate’s success on Wednesday, just as large swaths of the United States are seeing a surge in new cases and the world braces for flu season.

The 95% efficacy involves trial participants who had never been infected with SARS-CoV-2, the novel coronavirus that causes Covid-19 and is measured seven days after they received the second of two doses. Of 170 confirmed cases of the virus among these trial participants, 162 received the placebo and just eight had been given the vaccine candidate, the drugmaker said in a statement.

Importantly, efficacy was consistent across all participants and very few reported serious side effects, Pfizer said. This means the vaccine has crossed an important safety milestone that will allow the company to apply for emergency use authorization with the U.S. Food and Drug Administration.

News of a vaccine arrives nearly nine months after the virus first arrived in the U.S.

Since the onset of the pandemic, over 11 million confirmed cases of Covid-19 have been reported in the U.S. and 250,000 are dead according to Johns Hopkins University.

Earlier this month, Pfizer announced its vaccine candidate was 90% effective at preventing the disease, but the latest data shows the vaccine is even more effective across age, race and ethnicity groups.

“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. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Pfizer CEO Dr. Albert Bourla in a statement. “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.”

Roughly 44,000 people participated in the trials across the globe, Pfizer said.

The news comes after drugmaker Moderna announced its own vaccine is 94% effective based on its studies of more than 30,000 volunteers from across the U.S.

“This is a pivotal moment in the development of our Covid-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible,” said Moderna CEO Stéphane Bancel in a statement.

Government officials have been bracing for the arrival of a viable Covid-19 vaccine as well as the headache of inoculating an entire nation.

In October, California Gov. Gavin Newsom said health officials have been evaluating the logistics of delivering an eventual vaccine. That could take two different courses, as the Moderna and Pfizer candidates each have their own set of rules for cold storage. This in turn will result in demand for cold storage facilities, trucks and other variables that may lead to a shortage similar to what the country experienced with personal protective equipment, like N95 face masks and gloves.

Despite the positive developments about two possible vaccines, Dr. Anthony Fauci, the nation’s chief infectious disease specialist, said people should not throw caution to the wind and should instead continue wearing their face masks and keeping their distance from people who don’t live in their homes.

When a vaccine is approved by the FDA it will first go to the elderly, people with preexisting conditions and health care workers.

“At best, what we will see, will that be some people — generally the highest priority, that’s determined by an advisory committee and ultimately the CDC — there will likely be some getting vaccinated towards the end of December,” Fauci told NPR earlier this week.

Manufacturing enough vaccines for 20 million people will take time and Fauci said it probably won’t be until mid-2021 when the general population is able to get vaccinated.

Still, the prospect of a vaccine feels like a light at the end of a tunnel, even if it comes as the U.S. and the world enter flu season. The uncertainty of whether someone has the flu or the virus will weigh heavy on many people’s minds as the Covid symptoms often mimic those of the flu.

That uncertainty has weighed on health care workers since the onset of the pandemic.

ICU nurse Valerie Ewald at UCLA Medical Center in Santa Monica said it’s never been like this before — the feeling of not knowing what’s next, who might have the virus and if there’s another surge on the way.

“Just because we don’t know what’s coming. Since March we’ve felt like this. Even when the numbers went down, even after a holiday, we just were all waiting,” Ewald said in an interview. “All of us at the hospital wonder: Is one of us is going to take it home to our families? Am I going to have it and give it to my husband? This is the one that most of us find the terrifying.”

As the Midwest states see a particularly sharp spike in cases that shows no sign of letting up, Ewald wonders if that is going to happen in California and if the current surge is going to only get worse. Like Fauci, she hopes people don’t give up on whatever infection control measures they’re following and do their research — but also listen to the scientists when it comes to the vaccine.

“It’s so sad that wearing a mask has become so political,” said Ewald. “It’s hard to know how to get through to people sometimes. I’ve seen people in the ICU think they’re going to get better faster — and they’re just surprised by the virus.”

Like the Spanish Flu of 1918, health care workers in 2020 are seeing a jump in cases as the weather begins to cool down and more people will show up at clinics and hospitals with flu-like symptoms only to find out they have a flu.

This week, the FDA announced the emergency approval of the first rapid Covid-19 home test developed by California-based manufacturer Lucira Health. The at-home, 30-minute nasal swab test will include a portable device that can display results at a vial with the sample is inserted.

The FDA’s approval of the test allows it to join a plethora of similar tests that can only be performed by a health care professional and processed in laboratories. The Lucira kit will still require a prescription according to the company’s statement.

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