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The Pfizer-BioNTech vaccine has now been shown to be 95% effective in preventing coronavirus and has met the necessary safety criteria for emergency clearance, the companies said.
Pfizer and BioNTech say they plan to ship the COVID-19 vaccine to the US regulator for emergency use approval “within days” after “no serious safety issues were reported.”
The UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), is also set to speed up the authorization of the vaccine after the government ordered enough for 20 million people.
Pfizer was the first company in the world to share phase 3 test results
The final efficacy analysis of the jab showed that 95% were protected from the virus within 28 days of the first dose, longer than when the results of the phase 3 trials were shared last week.
It also demonstrated 94% effectiveness among adults over 65, who are generally more vulnerable.
There were no serious side effects, and only 2% of the 43,000 participants reported headache and 3.7% reported fatigue, the companies said.
On November 9, Pfizer became the first company in the world to complete Phase 3 of its coronavirus vaccine trials, which showed 90% efficient.
The news was followed earlier this week by an announcement from the US pharmaceutical company. Modern that its own vaccine candidate had an equally promising 94.5% efficacy.
So far, the UK government has ordered 40 million doses of the Pfizer-BioNTech jab, enough for 20 million people, and five million, for use in 2.5 million patients, from Moderna.
American and German companies say they will be able to produce 50 million doses this year and 1.3 billion in 2021.
Pfizer Chairman and CEO Dr. Albert Bourla said: “The study results mark an important step in this historic eight-month journey to present a vaccine capable of helping end this devastating pandemic.”
“We continue to advance at the speed of science to compile all the data collected so far and share it with regulators around the world.”
The Pfizer and Moderna vaccine trials are two of around 12 worldwide, including one being developed by AstraZeneca and the University of Oxford, which are in the final stages of testing.
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COVID-19 vaccine: Will it end the crisis?
Analysis: Biggest News So Far Provides Massive Mark on COVID Vaccine Wish List
By Thomas Moore, Science Correspondent
Of all the exciting recent news about COVID vaccines, this is perhaps the most significant of all.
The Pfizer-BioNTech vaccine works for the people who need it most. In those over 65 years of age, it was more than 94% effective against the disease.
It’s a huge tick on a vaccine wish list.
The immune system of older people generally doesn’t work as well as that of younger people.
But the most recent data shows that the vaccine is almost as effective in people of all ages.
The companies also say the vaccine’s overall effectiveness is now 95%, up from the 90% suggested by last week’s interim analysis.
That’s the same as the Moderna vaccine, which uses similar technology.
Clinical trials in just over 43,000 volunteers found no serious safety concerns. Some had headaches and fatigue, but that’s not unusual for a vaccine.
A great scientific question remains. How long does immunity last? If people need regular booster doses, the manufacturing capacity will increase even more.
The answer will come from continuous monitoring of antibody and T cell levels in people who have received the vaccine.
In the short term, the success of this vaccine will depend on logistics.
Its activity depends on the dry ice and the tightly insulated container that keeps it at minus 70 ° C for up to 15 days. Raise the temperature only 10 degrees and it may not work.
It is a smart and effective vaccine. Now the NHS and its providers must get you where you need it and quickly.
