Global efforts geared towards finding a cure for the dreaded Coronavirus (COVID-19) pandemic produced a major breakthrough yesterday as pharmaceutical giant, Pfizer Incorporated and its partner, BioNTech, unveiled their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2. The vaccine has demonstrated 90 per cent efficacy against COVID-19 in candidates without prior evidence of SARS-CoV-2 infection.
The vaccine has been tested on 43,538 people in six countries, with 42% having diverse backgrounds, and no safety concerns have been raised. The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.
Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The silver lining on the gloomy cloud is based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
Medical experts have described it as a major victory in the fight against a pandemic that has claimed over a million lives and battered the global economy. The first successful interim data followed a large-scale clinical test that showed vaccines could halt the pandemic. However, a mass roll-out of the vaccine, which needs regulatory approval, would not be possible this year.
The companies behind the vaccine said they had so far found no serious safety concerns and would seek authorization of the United States this month for emergency use of the vaccine as soon as possible. If the companies receive the approval, they can roll out an estimated 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
However, there are still many uncertainties surrounding the vaccine, such as how effective it is for vulnerable groups and how long it will provide immunity. Therefore, the “new normal” of social distancing and face masks may remain for the foreseeable future. Chairman and CEO, Pfizer Incorporated, Dr. Albert Bourla, has described the feat as a critical milestone in vaccine development at a time the world is in dire need of an effective antidote to the pandemic. “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. “We are reaching this critical milestone in our vaccine development programme 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 muchneeded 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. “I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavour. We could not have come this far without the tremendous commitment of everyone involved,” Bourila said.
Co-founder and CEO, BioNTech, Prof. Ugur Sahin, has described the effectiveness of the experimental vaccine as victory for innovation, science and global collaborative effort. “The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19.
“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 enrol 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,” Sahin said.
The companies in consultation with the United States Food and Drugs Administration (FDA) recently elected to drop the 32- case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.
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 continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide. U.S. President Donald Trump welcomed the test results: “Stock market up big, vaccine coming soon. Report 90% effective. Such great news!” he said on Twitter.
Also, U.S. President-elect Joe Biden has hailed yesterday’s announcement of an effective COVID-19 vaccine by Pfizer and BioNTech. Biden described the announcement as excellent news and congratulated the manufacturers for giving the world “cause for hope”.
However, Biden warned against complacency, noting that the end of the battle against the pandemic was still months away. He said even if a vaccine was approved by the end of November as forecasted by industry players, widespread vaccination would take many more months.
The president-elect emphasised the need for people to remain precautious, especially with the use of masks, which he said remained a “more potent weapon against the virus than the vaccine”.
“Today’s news does not change this urgent reality. “Americans will have to rely on masking, distancing, contact tracing, hand washing and other measures to keep themselves well safe into New Year,” he said.
President Muhammadu Buhari has called for its equitable distribution among countries. Buhari in a statement made available to newsmen yesterday by his spokesman, Malam Garba Shehu, welcomed the arrival of first effective coronavirus vaccine after a successful human trial phase.
Responding to Pfizer’s claim that the vaccine has recorded 90 per cent effectiveness against the disease, the President described the development as a major milestone in medical advance but warned that the world must unite in facilitating the equitable access and distribution of these vaccines to protect people in all countries. He reiterated his earlier call that “only a People’s Vaccine with equality and solidarity at its core can protect all of humanity and get our societies safely running again. A bold international agreement cannot wait.”
German Health Minister Jens Spahn has described the announcement of a promising experimental vaccine as ‘very encouraging.’ Spahn said that an initial analysis of phase 3 clinical trial data showed that “the vaccine makes a difference.” He said that a German company was among the first developers of a viable drug to prevent COVID-19. The prospect of a vaccine, according to Reuters report, electrified world markets with the S&P 500 and Dow hitting record highs as shares of banks, oil majors and travel companies soared.
Pfizer shares were 8.6% higher in New York at 1450 GMT, while BioNTech’s stock was up 11%. Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson JNJ.N up 4.5% and Moderna MRNA.O 5.5% stronger. Britain’s AstraZeneca AZN.L was down 3.5%.