Article by: Azka Gauher
After extensive trials on thousands of people, the much awaited COVID-19 vaccines have been successfully developed. There are three major companies in the world claiming to have developed vaccines with more than 90% success rate. The companies which have announced their success and anticipate launch by the end of the year are Pfizer Inc., an American multinational pharmaceutical corporation, BioNTech SE, a German biotechnology company. Both Pfizer and BioNTech jointly developed the vaccine while Sputnik V, a Russian COVID-19 vaccine candidate developed by the Gamaleya Research Institute of Epidemiology and Microbiology has made similar assertions. All three of the companies have claimed efficacy over 90%.
BioNTech & Pfizer projected the launch of the vaccine by the mid of next year. But the launch is now expected sooner than later. Explaining the modus operandi and the success rate Pfizer mentioned that the case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
“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.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen. 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. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioN- Tech co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
“Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” said Pfizer’s official statement.
On the other hand, the Russian COVID-19 vaccine candidate Sputnik V also announced their success rate same as Pfizer and BioNTech. It announced that Phase 1 and 2 clinical trials of the vaccine have been completed on August 1, 2020. All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine-induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine. Post-registration clinical trials involving more than 40,000 people in Russia and Belarus were launched on August 25, 2020. A number of countries, such as UAE, India, Venezuela, Egypt, and Brazil will join the clinical trials of Sputnik V locally. The vaccine has received a registration certificate from the Russian Ministry of Health on August 1.
Alexander Gintsburg, director of Moscow’s Gamaleya Institute which developed the Russian vaccine candidate, said he welcomed the Pfizer’s announcement about their success rate.
“In the near future, we expect to publish interim results of the post-registration trial of the vaccine Sputnik V, the so-called Phase III trials. I am sure that its effectiveness level will also be high,” he said.
Russia is gearing up to publish preliminary results of an ongoing large-scale human trial, known as Phase III, in the month of November.
It is indeed good news for the world that very competent scientists have been able to concoct a solution to the ongoing global threat which not only took lives but also wrecked the global economy. The fear that had been developed and following despair will finally be threatened for people to feel safer than before. With the hope that the vaccines are accessible and affordable for all races and strata of society, we finally put COVID-19 to bed.