In new development, a coronavirus vaccine being developed by collaborative efforts of the pharmaceutical company Pfizer and the German firm BioNTech, has shown great promise in early results. These findings were published today on the online platform, medRxiv, as a pre-print.
The vaccine called, BNT162b1, triggered even a stronger immune response than the one seen in people recovering from a natural infection.
— medRxiv (@medrxivpreprint) July 1, 2020
IMPORTANT: Pfizer’s Early Positive Data for Vaccine Against COVID.
Potentially 100 million doses by end of 2020, & over 1 billion by end of 2021
Yes, capitalism has terrible flaws which we MUST fix. But it is also an extraordinary engine for progress. https://t.co/wTMi8WaBmE
— Norm Eisen (@NormEisen) July 1, 2020
In the small study, scientists screened 76 subjects, and 45 participants were eventually randomized and vaccinated. Twelve participants per dose level (10 μg and 30 μg), were vaccinated with BNT162b1 on Days 1 and 21 and 12 participants received a 100 μg dose on Day 1 only. Nine participants received a placebo.
The study participants consisted of healthy male and female participants with an average age of 35.4 years. Participants were from white as well as non-Hispanic/non-Latino ethnicities.
For results, scientists measured antibody (RBD-binding IgG) concentrations and SARS-CoV-2 neutralizing titers at baseline at 7 and 21 days after the first dose and 7 and 14 days after the second dose of BNT162b1.
Today, we announced early positive data from the #US and as part of our global #COVID19 development program in collaboration with @pfizer. Find the key facts in our press release: https://t.co/YyvaOE49eP pic.twitter.com/9XemM0jJ4C
— BioNTech SE (@BioNTech_Group) July 1, 2020
By 21 days after the first dose mean concentrations of the antibodies were at 534-1,778 U/mL, for all three dose levels. In comparison, 38 people who have had a natural COVID-19 infection had antibody concentrations at 602 U/mL.
By 7 days after the second dose (for the 10 and 30 μg dose levels), the antibody concentrations were at 4,813-27,872 U/mL. These antibody concentrations among participants who received one dose of 100 μg BNT162b1 did not increase beyond 21 days after the first vaccination.
In the participants who received the 10 and 30 μg doses of BNT162b1, highly elevated antibody concentrations persisted to the last time point evaluated, at 14 days after the second dose. These antibody concentrations were 5,880-16,166 U/mL compared to 602 U/mL in the human convalescent serum panel.
The pharmaceutical giant and BioNTech, are testing four vaccine candidates right now. All these vaccines are based on a technology platform that delivers RNA, genetic material that turns the body’s own cells to turn into vaccine factories.
These currently published results are from one of the candidates, and the company said in a statement that it plans to use the data to select a dose and candidate to proceed to a large, 30,000-person trial that could begin at the end of the month, pending regulatory approval.
Moderna's sizable lead in the coronavirus vaccine race is vanishing.
Pfizer — using the same mRNA technology as Moderna — has adopted an equally speedy timeline. Both companies are aiming to start 30,000-person efficacy trials in July https://t.co/wvsdCoYd10
— Andrew Dunn (@AndrewE_Dunn) July 1, 2020
This is objectively good news.
Pro: Pfizer can scale up production quickly
Con: CEO has stated Pfizer wants to profit off this https://t.co/yDcGRpEDBs
— Topher Spiro (@TopherSpiro) July 1, 2020
The study is not yet peer-reviewed and it is unclear if these antibody levels are enough to prevent a person from getting sick. However, these results do support moving to a larger clinical trial to test out the vaccine.
One of the downsides of this vaccine candidate is the side effects observed in the patients. The majority of people given an intermediate dose of the vaccine developed fevers, chills and other low-grade symptoms that lasted a day. The scientists working on the vaccine have said that they will keep a close eye on such side effects when carrying out the large-scale trial.
If these are all the side effects that will be due to this vaccine, then it is not a serious cause for concern. Many other vaccines that are used have such side effects too. The shingles vaccine Shingrix, might may you sick enough to skip work for one day also. But in the end the benefits outweigh the cons. Only time and future trials will tell if BNT162b1 falls under the same category.
Experts are praising the company’s effort to share data in a detailed way. Previously other companies working have shared partial data in many cases which has frustrated the scientific community.
I was glad to see @pfizer put up their phase 1 trial data today. Virus neutralizing antibody titers achieved after two doses are greater than convalescent antibody titers. Maybe the first objective good news we've seen out of Operation Warp Speed?https://t.co/uzp4bKkpAm
— Prof Peter Hotez MD PhD (@PeterHotez) July 1, 2020
The biotechnology company Moderna gave a glimpse of its early data through a news release in May and is expected to begin its large clinical trial this month. But the company has yet to share full results from its initial safety study, which will be published by scientists at the National Institutes of Health.
Inovio Pharmaceuticals, a company working on a DNA vaccine also announced positive results via news release this week. The incomplete data have upset scientists trying to evaluate the different approaches.