BALTIMORE — On Monday night we were closer to a potential Coronavirus vaccine.
Pfizer Incorporated and BioNTech announced they’ve created a vaccine that is 90% effective in preventing Coronavirus.
Dr. William Moss is a professor in the Department of Epidemiology and the Executive Director of the International Vaccine Center at the Johns Hopkins Bloomberg School of Public Health.
He said the vaccine announcement is encouraging and exciting.
If the 90% threshold holds once the full study is released, he says that is much higher than anticipated.
“The Food and Drug Administration set a threshold of 50% so much lower threshold for a vaccine for which they would consider an emergency use authorization," Moss said.
In a statement Dr. Albert Bourla the Chairman and CEO of Pfizer said “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”
The study looked at more than 43,000 patients and did not detect any serious safety concerns.
Dr. Moss said this is great news but there are still many questions.
"We don’t know how long this protection is going to last," Moss said. "We don’t know yet whether we’re going to see 90% vaccine efficacy in older adults who are the most vulnerable.”
Dr. Moss hopes the data will be made public.
To meet the FDA guidelines half the people who took the vaccine must have at least two months of follow up.
Pfizer said they will meet that threshold by the third week of November.
After that there will be a review process by an expert panel and then the FDA will determine whether to issue an emergency use authorization.
“Making sure at least in the short term that there are no signals that this vaccine can cause serious adverse events. Some adverse events are going to be tolerated, they are expected," Moss said. "We know from this vaccine it causes fevers some fatigue maybe some muscle aches those kind of things are going to be expected.”
The reason it’s broken up into two doses over a few weeks' time is to make sure the person gets enough of it.
Dr. Moss emphasizing this is not the magic bullet and that if we’re lucky we will have an approved vaccine that will go to health care workers and the most vulnerable.
He doesn’t expect a vaccine to be available to the public until mid 2021.
A lot of people are wary of a vaccine especially one that came so quickly, but Moss said procedures have been followed to ensure the safety of the vaccine in the short term.
“It doesn’t mean that it’s been done hastily or sloppily or without concern for safety.”
Emergency use authorization is expected by the third week of November.
Pfizer and BioNtech are preparing to submit to the FDA and they expect to be able to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion in 2021.