Pharmaceutical companies Pfizer And BioNTech have announced the interim results of their ongoing Covid-19 vaccine phase 3 trial. The vaccine appears to be 90 percent effective, and there have been no safety concerns.
The phase 3 trial began on July 27 and has so far enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of yesterday. The participant comes from the US, Germany, Brazil, Argentina, South Africa, and Turkey. Protection in patients was achieved a week after the second dose, and 28 days after the first. The vaccine was found to be more than 90 percent effective in protecting against Covid-19 in patients that had not had SARS-CoV-2 already.
The announcement also confirmed that so far, no serious safety concerns have been observed. Data from the previously published clinical trial phases suggests that the side effects for the vaccine are consistent with what has been seen in other vaccines for adults, such as the flu and pneumonia shots.
“Today is a great day for science and humanity. The first set of results from our Phase 3 Covid-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent Covid-19,” said Dr Albert Bourla, Pfizer Chairman and CEO said in a statement. "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 two companies announced that they will be able to produce 50 million doses by the end of the year and 1.3 billion in 2021. The study is also evaluating the potential for the vaccine candidate to provide protection against Covid-19 for those who have had prior exposure to SARS-CoV-2.
This result is certainly exciting but it is important to note that this is an interim result. The researchers will need longer to confirm the correct efficacy of the vaccine, which might decrease or increase as the final data is analyzed over the next few weeks. Pfizer and BioNTech estimate two months of safety data following the second (final) dose needs to be procured before results can be confirmed. This is also the same amount of time specified by the FDA for potential Emergency Use Authorization.
As soon as the data is available the research will be submitted for peer review and the vaccine will be submitted for approval to government agencies across the world.
If the vaccine is approved it would make this the first approved vaccine using the mRNA technology. In this approach, a non-dangerous bit of genetic material from the virus is injected into the human body. Our body produces the protein coded in that genetic piece and our immune system is quickly trained to recognize it as hostile and fight back.