A Covid-19 vaccine in 2020 will not be anything short of a miracle. Scientists have engaged in what will become the fastest vaccine race to be developed if it becomes available in the coming weeks. The second wave is raging across the world and the third wave is anticipated to be more devastating. Countries like the Czech Republic and Germany have made plans for administering the vaccine when it is ready.
Fierce Efforts For The Vaccine Globally
The 2020 race for a Covid-19 cure has been characterized by fierce and competitive efforts by biologists, researchers, and investors, and government institutions with the aim of arriving at a common goal. Such races could be distilled into two directions: the race for a rapid Covid-19 home test and the race for a successful vaccine against the virus.
Since the first case of the novel Covid-19 was confirmed in Wuhan in December 2019, there have been more than 52 million confirmed cases worldwide according to European Centre for Disease Prevention and Control (ECDC) daily situation update. Biotech companies have also committed to devising a-low-cost-easy-to-manufacture Covid-19 home test kit.
The Unusually Short Time Frame
The time frame to develop a vaccine according to experts usually runs in years but with the number of confirmed cases doubling up, efforts to produce a vaccine, which would help create antibodies against the disease, have tripled at an unprecedented speed.
Amid fears for the speed at which companies are working to contain the pandemic and the possible consequences of such hurriedly developed vaccines, vaccine developers including Pfizer, GlaxoSmithKline, and AstraZeneca, in a joint statement on Tuesday, made a “historic pledge… to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first Covid-19 vaccines,” according to Reuters.
674 Drugs And Vaccines In Development Globally
In a report updated on August 28th, Statista stated that 674 drugs and vaccines are under development worldwide for the cure of the novel virus. The drugs and vaccines are categorized according to their phases of development out of which 509 of them are at the preclinical stage, 48 currently undergoing the phase I clinical-stage, 77 have reached the phase II clinical stage while 29 have soared to the phase III clinical stage. Only three have made it to the pre-registration clinical stage and one has been registered.
Additionally, Jonathan Rothberg, an inventor, and entrepreneur, also declared in a tweet on March 7th that he was thinking about “a low cost easy to manufacture home test kit for #Coronavirus.” Many other biotech companies are also in a similar race with Rothberg.
Pfizer and BioNTech Collaboration
Pfizer (PFE) and BioNTech (BNTX) collaboration have the most promising prospects in the race for a safe and effective vaccine and drug against Covid-19. In their July press release, the two companies projected that they may supply up to 100 million doses of the vaccine by the end of 2020 and more than a billion doses by the end of 2021 if their phase 2/3 study is successful and a regulatory authorization is obtained.
Pfizer and BioNTech are working on a unique type of vaccine called the messenger- Ribonucleic Acid (mRNA). Messenger – RNA is an information-carrying bio-molecule that instructs the body cells to make copies of the S protein of the virus, recognize it and then build antibodies to fight it once it attacks. After their successful phase 2 clinical study, the two firms chose to advance their BNT162b2 vaccine candidate into the phase 2/3 study.
“Our selection of the BNT162b2 vaccine candidate and its advancement into a phase 2/3 study are the culmination of an extensive, collaborative, and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.
Recently, Pfizer and BioNTech reported that their phase 3 clinical trial yielded more than 90% efficacy in preventing coronavirus infection in participants without evidence of a prior case of COVID-19. “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,” according to the company’s report.
The news came as a huge relief following the massive second wave of the virus which appears to be more devastating than the first wave. In their clinical trial analysis, 94 participants with Covid-19 infection were evaluated
AstraZeneca and Oxford University ChAdOx1 nCoV-19 Vaccine Race
In their bid to arrest the Covid-19 menace, Oxford University research institute teamed-up with AstraZeneca. They are working on a type of vaccine which combines a weaker version of the common cold virus with some genetic material from the SARS-CoV-2 virus.
On September 2nd, Oxford announced that their ChAdOx1 nCoV-19 vaccine was expanding into the U.S. phase 3 clinical trials. Late-stage clinical trials are ongoing in the UK, Brazil, and South Africa and led by Professor Pollard of Oxford University. More trials are planned to start in Japan and Russia, to be led by AstraZeneca.
Across trial centers in the US, up to 30, 000 adults are being recruited from the age of 18 and above and from diverse ethnic groups. The participants range from people who are healthy or have stable underlying medical conditions, to people with HIV as well as those at a higher risk of Covid-19 infection. If clinical trials become successful, they plan to produce over 3 billion shots of the virus globally and “as rapidly as possible.”
But the company recorded a major hitch in the race and announced on September 8th that its clinical trials worldwide would be put on hold. The company is now investigating an adverse reaction in a trial participant in the UK. According to Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases (NIAID), “pauses are not unusual”.
The pause had a significant impact on the timing for the team’s Covid-19 vaccine but they have been able to pick-up. Today AstraZeneca has reported that their vaccine is up to 90% effective.
Moderna Therapeutics and NIH Team
Moderna Therapeutics is another frontrunner in the quest for an effective vaccine. The mRNA vaccine distinguishes itself among other vaccines being produced in that it has a quicker development timeline. The vaccine can be administered with lower dosing requirements and can be produced in larger quantities rapidly. Moderna is collaborating with the National Institute for Health (NIH) thereby giving the collaboration a boost. Their vaccine candidate is the mRNA-1273.
In its October 22nd report, Moderna announced that it had completed phase 3 enrollment for the Covid-19 study of the mRNA-1273 vaccine candidate. The phase 3 study is called the Coronavirus Efficacy (COVE) and they are working in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and NIH. About 30,000 participants were enrolled in the randomized, placebo-controlled trial in the United States and testing an mRNA-1273 dosage of 100 µg.
Moderna plans to produce about 500 million shots of the Covid-19 vaccine per year and up to a billion beginning from 2021 if all the phase 3 clinical trials are successful. To enhance large scale production, and commercial manufacturing of mRNA-1273, Moderna plans to collaborate with Catalent Incorporations in the United States and with ROVI of Spain for fill-finish manufacturing outside the United States.
Sanofi and GlaxoSmithKline Collaboration
Sanofi and GlaxoSmithKline have demonstrated strong support in the quest for a Covid-19 cure. In a press release on September 3rd, they announced their entry into the phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine. 440 healthy adults are enrolled in the trial phase across 11 investigation sites in the United States. The phase 1/2 clinical trial is randomized and uses proven technologies to evaluate the safety, tolerability, and immune response of the Covid-19 vaccine participants.
This puts Sanofi and GSK collaboration ahead of other competitors and would be useful in the production of vast reliable quantities of the vaccine. The companies anticipate beginning a phase 3 trial in December if the results of the phase 1/2 trials are successful. Accordingly, they plan to request regulatory approval by mid-2021 if the data are sufficient for a licensure application.
Sanofi and GSK are committed to a global supply of the vaccine and have struck a deal with the U.S. government to supply up to 200 million shots of the vaccine as soon as possible and the UK with about 60 million doses. They plan to supply 500 million more in a long run.
Other Biotech and Pharmaceutical Companies on the Race
In China, there are about eight vaccine candidates that have received approval for human clinical tests of which the Ad5-nCoV is one of them. This vaccine candidate was developed by the Chinese military research unit, Academy of Military Science (AMS) and CanSino Biologics (6185.HK).
Canada has also approved the vaccine for a human trial. The vaccine has passed its phase 1 and 2 clinical trial stages but according to a statement released by the company and reported by Reuters, the vaccine “has the potential to prevent diseases caused by the coronavirus” and added that “its commercial success cannot be guaranteed.”
SinoVac and Dynavax, a Chinese-American collaborating company in the race for a Covid-19 vaccine, was announced to be at phase 1 clinical stage.
Novavax, Johnson $ Johnson are also actively involved in the quest for a cure for the disease. They are both reported to be in their phase 1 clinical trial stages
The Rapid Test Kit Race for Covid-19 Testing
While quarantining with his family aboard his yacht, Jonathan Rothberg developed a Covid-19 test kit that would be used for school children or at home for easy to use and rapid results. Other competitors in the U.S. are E25Bio, a Massachusetts biotech company that are yet to receive regulatory approval. Cue Health, a San Diego based company are also on their way to producing such test kits. In June, they raised a hundred million dollars from institutional and strategic investors to help achieve their cause. They have also received a E.U.A. for their twenty-five-minute rapid point-of-care test. Mammoth Biosciences is also part of the race to develop a CRISPR-based at-home test as soon as possible. Their partnership with GlaxoSmithKline was to boost the speed of producing the kit but it seemed unlikely to appear before next year. Homodeus has also made significant achievements in the race. They have not been allowed to market their test kits but they could plan with parties who are interested.
Despite increasing speed from the natural science research industries and with new developments from last week, experts have feared that an emergency Covid-19 vaccine may not be available by November this year. In speaking about the status of the vaccine in the U.S, Moncef Slaoui, the Operation Warp Speed head, told National Public Radio (NPR) it remains “extremely unlikely, but not impossible” a vaccine will be ready by early November. Until now, this seems to be the case worldwide.
If you find any mistakes or inaccuracies in this article, please don’t hesitate to contact us via email at info@regtechglobal.com
