Pfizer says the COVID vaccine is 95% effective and demands the FDA’s okay “within a few days”

Pfizer will finalize test data on Wednesday COVID-19 (new coronavirus infection) (# If there is no character limit, add parentheses when it first appears The vaccine, developed in collaboration with the German company BioNTech, is 95% effective and has shown to the US Food and Drug Administration to apply for an emergency license “within a few days.” Changing the course of the coronavirus pandemic, which killed more than 1.3 million people worldwide and nearly 250,000 in the United States alone, was the latest hopeful news for the world.

In a statement released earlier Wednesday, Pfizer said vaccine efficacy was consistent “beyond age, gender, race, and ethnic demographics,” and test data two months later are safe. Vaccine function that stated that it meets the criteria set by the FDA to demonstrate both sex and safety.

“Pfizer and BioNTech will submit EUA requests to the FDA within a few days. [Emergency Use Authorization] It is based on the entire safety and efficacy data collected so far. “

Pfizer became the first vaccine maker Last week claiming very high efficacy for the prescriptionPreliminary data show that it is more than 90% effective in preventing new coronavirus infections.Wednesday’s announcement made these results even more optimistic by linking and matching these results with the final data. Preliminary efficacy data reported by Moderna, Another American vaccine maker wanting to look for EUA in the US soon.

In a phase 3 human study involving more than 43,000 people, Pfizer showed that the vaccine was “well tolerated in all populations” and “no significant safety concerns were observed.” According to Pfizer, the only notable side effects were 3.8% of vaccinated malaise and about 2% of headaches.

What you need to know about the COVID vaccine trial


If approved for use by the FDA, the Pfizer vaccine will require the patient to receive two doses, the second 21 days after the first dose.

Both Pfizer and, in theory, Moderna were able to obtain urgent approval from the FDA in a short period of time, but widespread vaccination only after pharmaceutical companies were able to ship millions of vaccines worldwide. Initiatives will begin in earnest. And especially with Pfizer vaccines, it poses a significant challenge.

Pfizer vaccines should be kept nearly 100 degrees below 0 degrees Fahrenheit to remain effective. This is about 20 degrees lower than the extreme winter temperatures at the South Pole. Experts warned early on that the United States lacked the ultra-low temperature storage trucks and freighters needed to carry hundreds of millions of shipments at sub-zero temperatures.

To avoid that, Pfizer has developed a specially constructed frozen “suitcase” that can be tightly sealed and shipped even on unrefrigerated trucks. Pfizer may have solved the problem of how frozen vaccines are shipped, but these highly designed shipping containers require hospitals, pharmacies, and outpatient clinics to vaccinate, especially hundreds of millions of Americans. It causes other problems for the clinic.

“The reality is that no drug needs to be stored at this temperature,” said Saha Soumi, a premier pharmacist and advocacy director who buys from hospitals across the country. β€œThe management and distribution efforts must be done with all hands.”

Despite these challenges, the latest news from Pfizer could have been welcomed by the medical and scientific communities. Former FDA administrator Scott Gottlieb called the result a “game change” in a tweet earlier Wednesday.

Gottlieb, a member of Pfizer’s board of directors, noted the positive results of both Pfizer and Moderna: “Two vaccines that, hopefully, can effectively end the US epidemic next year. Is necessary. ”

State supports COVID-19 surge


The U.S. government is spending billions of dollars to support the development of many “candidate” vaccines that are still being tested around the world, but Pfizer’s management is funding the development of the drug Decided not to accept.

“We wanted to free our scientists from bureaucracy … when we get money from someone, it’s always tied up,” said CEO Albert Bourla.

Pfizer has signed a major production and delivery contract with the U.S. government, but after approval, it is worth up to $ 1.95 billion and an additional $ 500 million to secure the first 100 million doses of vaccine. You have the option to buy. Ministry of Health and Social Welfare.

Haley Ott of CBS News in London contributed to this report.

Pfizer says the COVID vaccine is 95% effective and demands the FDA’s okay “within a few days”

Source link Pfizer says the COVID vaccine is 95% effective and demands the FDA’s okay “within a few days”

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