Pfizer and German biotech company say they expect their coronavirus vaccine to be ready for approval by the end of the year as trials on 30,000 people begins
- Pfizer and its German partner BioNTech SE are entering large-scale human trials this summer for their coronavirus vaccine
- They expect results to come back relatively quickly and will seek FDA approval by the end of the year
- The jab uses part of the virus’s genetic code to develop antibodies and recognize the virus rather than using dead particles
- It generated levels of neutralizing antibodies between 1.8 and 2.8 times greater than those seen in recovered patients
Pfizer Inc and its German partner BioNTech SE say they expect their experimental coronavirus vaccine to be ready to seek regulatory approval by the end of the year.
SE co-founder and CEO Dr Ugur Sahin told The Wall Street Journal the company hopes to produce millions of doses before approval, and more than one billion by the end of 2021.
It comes on the heels of news that Pfizer and BioNTech’s COVID-19 immunization showed encouraging early results in a study of 45 people.
Volunteers given either a low or a medium dose had immune responses in the range expected to be protective when compared to COVID-19 survivors, according to the preliminary findings.
The experimental vaccine is expected to move into a large trial involving 30,000 healthy participants later this month, pending regulatory nod.
Pfizer and its German partner BioNTech SE are entering large-scale human trials this summer for their coronavirus vaccine. Pictured: The first patient enrolled in Pfizer’s COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection, May 4
The companies expect results to come back relatively quickly and will seek FDA approval by the end of the year. Pictured: Pfizer headquarters in New York City
‘It is in the nature of innovation to take center stage at a time of great urgency,’ Dr Sahin told The Journal.
‘The world has never seen such a rapid global development of new vaccines, just as it has not seen such a quick, global spread of a pandemic before.’
The vaccine candidate from Pfizer and BioNtech uses part of the pathogen’s genetic code to get the body to generate antibodies and recognize the coronavirus and attack it if a person becomes infected.
The Journal says this type of vaccine would be cheaper and easier to produce than vaccines that traditionally use dead or partially alive virus particles.
BioNTech says one batch of its inoculation would take between nine and 11 days to produce.
Although the company’s international partnerships would allow it to quickly manufacture and widely distribute the jab, the virus has already reached all corners of the globe.
Dr Sahin believes it will take at least 10 years to beat back COVID-19.
‘I assume that we will only be done with this virus when more than 90 percent of the global population will get immunity, either through infection or through a vaccine,’ he told The Journal.
For the study, three groups of 12 received either a 10-microgram dose, a 30-microgram dose or a 100-microgram dose. Nine were given a placebo.
The highest dose shot caused fevers in about half of the group, so a second shot wasn’t given.
Three weeks later, participants were given a second dose. Following that, 8.3 percent of the 10-microgram group and 75 percent of the 30-microgram reported fevers.
However, these side effects did not result in hospitalization, nor were considered life-threatening, and resolved after about one day.
The immunization generated not just antibodies against the virus but specifically neutralizing antibodies, meaning they stop the virus from infecting human cells.
Results showed the levels of neutralizing antibodies were between 1.8 and 2.8 times greater than those seen in recovered patients.
Volunteers who received one 100-microgram dose had lower levels of antibodies than those who were given two shots of the low or medium dose.
Following news of the preliminary results, shares of Pfizer rose by four percent last Wednesday.
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