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Covid-19 Vaccines: What’s Coming and When?
As countries and companies race to produce a safe and effective coronavirus vaccine, here’s a guide to the front-runners
By Ana Rivas, Peter Loftus and Alberto Cervantes | The Wall Street Journal
Some 200 Covid-19 vaccines are in development around the world, according to the World Health Organization, each one promising to protect people from the deadly coronavirus and allow them to go back to work and school.
Now, several have been authorized for use and are being rolled out in mass immunization programs, while nearly a dozen are in or nearing the final stage of testing. The U.S. authorized the Pfizer/BioNTech vaccine on Dec. 11, joining the U.K. and Canada. The European Union is expected to approve the Pfizer vaccine in December. Chinese and Russian authorities have already approved some state-developed vaccines for “emergency use,” although trials are still under way.
The Front-Runners
A vaccine candidate by Moderna Inc. and one developed jointly by Pfizer Inc. and partner BioNTech SE, have shown very positive late-stage trial results. The Pfizer/BioNTech vaccine was authorized in the U.S. on Dec. 11, after being greenlighted in the U.K. and Canada. The Moderna vaccine is also on track for potential U.S. regulatory clearance by the end of 2020. Both vaccines use a novel gene-based technology to provoke an immune response.
The University of Oxford and AstraZeneca PLC also have an experimental shot in final-stage testing.
Regulations for vaccine development and rollout vary world-wide. Chinese institutions have four vaccine candidates in the final stages of testing. Russia in August became the first country in the world to approve a state-developed vaccine—which it did before any advanced clinical testing—and has since approved a second one with plans for a third under way. Russia, China and the United Arab Emirates are allowing some of their citizens to get vaccinated before clinical trials wrap up.
Many vaccines that show promise in early testing fail during the final round. Trials involving two of the top-runners, developed by AstraZeneca and Johnson & Johnson, JNJ -2.54% were paused or halted because of illness in study subjects—developments that aren’t unusual in large clinical trials—but the studies have resumed. While final-stage testing may stretch for months or even years to continue to track safety and the durability of protection, positive interim results from Phase 3 can be enough for a vaccine to start getting regulatory approval for mass production and distribution in the meantime. Some of the leading vaccine candidates have released interim results, and more are expected in the coming weeks or months.
The Oxford/AstraZeneca vaccine is designed to provide protection by delivering into a person’s cells the genetic code for the spikes protruding from the new coronavirus. Then the cells can produce the spike proteins, generating an immune response that would be able to fight off the coronavirus.
Delivering those genetic instructions is a weakened, harmless version of a virus that causes the common cold in chimpanzees. In early testing, the vaccine successfully produced immune responses in humans with only minor side effects.
In November, AstraZeneca said a preliminary analysis showed the vaccine was effective at preventing Covid-19 in large clinical trials in the U.K. and Brazil, and the company planned to seek regulatory clearance globally. In early September, AstraZeneca had suspended trials globally for its vaccine candidate after a woman in the U.K. experienced illness. The company resumed its U.K. study after investigating the incident, and in October restarted a U.S. study aiming to enroll 30,000 subjects. Other late-stage trials including those in Brazil and South Africa have resumed.
- Production capacity estimate: AstraZeneca aims to make up to three billion doses world-wide in 2021.
The Moderna vaccine also uses a gene-based technology to provoke an immune response, though the code it delivers takes the form of messenger RNA. Those molecules, commonly referred to as mRNA, are the body’s molecular couriers ferrying DNA instructions for making proteins. The vaccine delivers to cells mRNA for making the coronavirus’s spike protein.
Moderna and the U.S. National Institute of Allergy and Infectious Diseases are testing a two-dose shot. The shot has shown to be highly effective at protecting people from Covid-19 symptoms, according to a preliminary analysis of results from final-stage testing announced in mid-November. The 30,000 person trial continues in the U.S.
It was the first candidate to enter human testing in the U.S. The vaccine produced an immune response in early-stage testing and was generally well-tolerated, with minor side effects observed in test subjects. An mRNA vaccine has never been approved for any disease.
- Production capacity estimate: 20 million doses by the end of 2020; 500 million to one billion doses a year starting in 2021.
The vaccine developed by Pfizer and German partner BioNTech SE BNTX -14.95% also uses mRNA. Phase 3 testing began in the U.S. in July and expanded overseas to include about 120 sites. The study enrolled 44,000 people. The vaccine reached a development milestone in early November, proving to be more effective than expected at protecting people from Covid-19.
In the U.K., the two-shot vaccine began to be rolled out in December after having won regulatory approval.
The U.S. FDA authorized Pfizer’s vaccine for emergency use on Dec. 11 and the first immunizations outside of clinical trials began within days, with 25 million doses expected to be distributed by the end of the month.
Pfizer filed for U.S. regulatory clearance on Nov. 20, and the U.S. FDA authorized the vaccine’s use on Dec. 11. The vaccine will go into distribution in December, though it will take months for the companies to make enough doses for the general population.
The U.S. government has agreed to pay Pfizer and BioNTech nearly $2 billion for 100 million doses.
- Production capacity estimate: up to 50 million doses world-wide by the end of 2020, and about 1.3 billion by the end of 2021.
China’s state-owned Sinopharm is developing two vaccines with the government agencies Wuhan Institute of Biological Productsand Beijing Institute of Biological Products. Both are based on an older vaccine-making technique.
The United Arab Emirates, which was one of several countries where Sinopharm conducted Phase 3 trials, has said the vaccine showed to be 86% effective in protecting people against Covid-19 in Phase 3 trials. However, the U.A.E. didn’t disclose details of its analysis, and public-health experts said more information was needed to gauge the reliability of the efficacy estimate.
Nearly one million Chinese people have already received shots from Sinopharm, which the government approved for “emergency use” in July for medical workers and border-inspection officials. The U.A.E has registered Sinopharm’s vaccine, paving the way for broad use, after having approved it for emergency use in September.
- Production capacity estimate: about 220 million doses a year.
Sinovac, a private Chinese company, began its final-stage trial in July in São Paulo, Brazil, where it is testing its vaccine to take advantage of a higher infection rate. Sinovac has also struck a deal with Indonesian state-owned pharmaceutical holding company PT Bio Farma to make up to 250 million vaccine doses each year for the Indonesian public, according to China’s state news agency.
- Production capacity estimate: about 300 million doses a year at a Beijing plant.
CanSino’s vaccine is aimed initially at the Chinese military. Chinese company CanSino developed the shot with the military based on a weakened virus behind the common cold. A Phase 1 study was conducted in March in Wuhan, the early epicenter of Covid-19. The shot got government clearance in June for military use for one year.
- Production capacity estimate: 100 million to 200 million doses a year starting in 2021.
Johnson & Johnson is developing a vaccine that uses a weakened form of a common-cold virus, known as an adenovirus. A single dose of this vaccine provoked a strong immune response in early animal testing. The company in September started a 60,000-person global study, which could be the largest late-stage clinical trial of a Covid-19 vaccine. On Oct. 12, Johnson & Johnson said it paused all of its clinical trials because of unexplained illness in a study volunteer, while an independent data-safety monitoring board reviews what happened. The company resumed the large international trial later in October after concluding there was no evidence the vaccine caused the illness.
The study is being conducted at nearly 215 locations in the U.S. and eight other countries where transmission rates are high, including Brazil, Chile and South Africa.
- Production capacity estimate: one billion world-wide by the end of 2021, including 100 million doses for the U.S., with an option for an additional 200 million, and 30 million doses for the U.K., with an option for an additional purchase of up to 22 million.
The Russian state-owned Gamaleya Research Institute has developed a vaccine based on a combination of two adenoviruses. The vaccine was tested on volunteers and Russia effectively approved its use in early August, though trials are ongoing. In mid-November, the Russian government said early results from a large-scale trial of 40,000 volunteers showed high efficacy against Covid-19—92%—and no unexpected adverse side effects. The data aren’t peer-reviewed. A rollout is expected to begin in December with two million shots this year.
- Production capacity estimate: 30 million doses a month by March for domestic use.
Novavax’s NVAX 3.86% vaccine consists of two shots given 21 days apart that deliver proteins resembling the spike jutting out from the new coronavirus. Researchers hope the proteins will trigger the production of antibodies and immune cells that can fight off the coronavirus.
The shots also contain a component, called an adjuvant, to boost the immune response. In early-stage testing, the vaccine was generally well-tolerated and produced promising numbers of antibodies. The company in late September started a Phase 3 study in the U.K that has been expanded to include 15,000 people. A separate Phase 3 study in the U.S. and Mexico is expected to begin in the coming weeks.
- Production capacity estimate: Novavax has said it could produce 100 million doses for use in the U.S., with delivery beginning by the end of this year, and a global manufacturing capacity of over 2 billion doses annually when at full capacity in 2021. Novavax said in October it has experienced some delays from its original timing estimates.
Bharat Biotech of India, in collaboration with the Indian Council of Medical Research, has developed a vaccine, Covaxin, using an inactivated virus strain. A university in India said a Phase 3 trial of the vaccine began there in mid-November.
Anhui Zhifei Longcom Biopharmaceuticals began a phase 3 clinical trial for its recombinant protein vaccine candidate in December, according to the WHO. State-run China Global Television Network in November reported that a one-year trial would take place in Uzbekistan and aim to recruit 5,000 volunteers. Anhui Zhifei is a unit of private firm Chongqing Zhifei Biological Products. It is co-developing the vaccine with the Chinese Academy of Sciences, a government institution.
Medicago, a Canadian biopharmaceutical company, has moved its virus-like particle vaccine to Phase 2/3 trials in Canada and is seeking to do the same in the U.S., pending approval. from the FDA. Medicago is developing the vaccine with GlaxoSmithKline PLC.
The vaccine uses Medicago’s technology to produce in plant leaves the spike protein from the coronavirus. The proteins are made into virus-like particles that present as antigens to trigger an immune response to the virus. These virus-like particles are administered with Glaxo’s adjuvant, a vaccine component that helps boost the immune response and can reduce the amount of virus-like particle antigen needed for each dose.
—Jonathan D. Rockoff, Chao Deng, Raffaele Huang, Yan Wu, Georgi Kantchev, Jared S. Hopkins and Dasl Yoon contributed to this article.
Corrections & Amplifications
China National Pharmaceutical Group Co., or Sinopharm, has two vaccines in Phase 3. An earlier version of this article incorrectly said a vaccine. (Corrected on Sept. 3)
Write to Ana Rivas at [email protected], Peter Loftus at [email protected] and Alberto Cervantes at [email protected]
