The coronavirus vaccine developed by US pharmaceutical company Pfizer and its German partner BioNTech will be presented for emergency approval by regulatory bodies "in a matter of days," both companies announced Wednesday.
The final analysis of the vaccine trials, they added, suggests that its efficacy
is even higher than previously thought, and that it is safe
.
The two companies said their phase 3 trial was now complete and that the test results reflected that the vaccine is 95% effective in preventing COVID-19, compared to the 90% announced last week.
[Two vaccines against COVID-19 show promising results, what are their differences and similarities?]
On Monday, the pharmaceutical company Moderna, a competitor of Pfizer, said that the initial efficacy of the vaccine it develops was close to 95%.
"Now we have two vaccines that are really quite effective," Anthony Fauci, director of the National Institutes of Allergies and Infectious Diseases, said after the news broke. "It's a big step," he added.
Pfizer-BioNTech tests have not revealed serious side effects among the 41,135 adults who received two doses of the vaccine, both companies reported in a joint statement.
The most common reactions were that
3.7% of the participants experienced fatigue and 2% suffered a headache
, they detailed.
[What is the 'cold chain' and why despite Fauci's optimism the Pfizer vaccine is not expected in pharmacies anytime soon]
In total, 170 confirmed cases of COVID-19 were detected among the participants, of whom only eight people had received the vaccine, while the other 162 had been given a placebo.
The companies have yet to release detailed data on their study and the results have not been analyzed by independent experts.
Both reported that the vaccine was
more than 94% effective in adults over 65
, a higher risk group because other vaccines are known to be less effective for them.
Older people are also at a higher risk of becoming seriously ill from COVID-19.
“This is a big step,” Fauci says of Moderna's announcement of vaccine advances.
Nov. 17, 202002: 30
However, it is unclear exactly how that was determined with only eight cases in the vaccinated group to analyze and a breakdown of the ages of those people was not provided, recalls The Associated Press news agency.
Still, this result looks hopeful.
"It's quite surprising," Akiko Iwasaki, an immunologist at Yale University, told The New York Times.
"We know from the influenza vaccine that it is very difficult to achieve protection in this age group with vaccines," he added, so the 94% efficacy in that population group, in his opinion, "is really remarkable."
Several public health experts
have called for caution
regarding the evaluation of the progress of experimental vaccines against COVID-19, especially before more specific data is published.
It is further anticipated that distributing any vaccine in the United States and the rest of the world will be a monumental logistical challenge.
[What measures are being taken to stop the rebound in coronavirus infections? We explain them, state by state]
The announcements in recent days have however been received as a hopeful sign in an otherwise bleak year, during which global deaths from coronavirus have soared above 1.3 million, nearly 250,000 of them in the United States.
If the approval of a vaccine happened this year,
that would exceed expectations in what is usually a very slow process
.
"The results of the study mark an important step in this historic eight-month journey to present a vaccine capable of helping end this devastating pandemic," said Albert Bourla, president of Pfizer, in the statement.
The number of minors diagnosed with COVID-19 exceeds one million in the United States.
Nov. 18, 202002: 12
The drugmaker and its partner said they will now submit a request for authorization for emergency use to the Food and Drug Administration (FDA), while sharing their data with regulators in Europe and elsewhere.
Regulators should review the evidence for both this vaccine and Moderna, but
evidence of success
suggests that both vaccines could be available to high-risk populations such as healthcare workers or individuals with pre-
existing
illnesses before the end of this year.
Vaccination of people in high-risk groups could take about four months and,
in April, the application of the doses could be expanded to all people
, according to current forecasts.
With information from NBC News, AP and The New York Times.
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