Vaccine development is a slow, painstaking process. First come the lab tests, then animal studies, and finally, a trio of human trial phases, each involving more people than the last.
Typically, that path to approval takes 10 to 15 years, but researchers are developing COVID-19 vaccines at a breakneck pace to combat the ongoing pandemic.
This coronavirus vaccine list highlights those either in the final stretch of the development process — phase 3 clinical trials — or already authorized.
Moderna's RNA Vaccine (mRNA-1273)
In March, Moderna's COVID-19 vaccine became the first to reach the human trial stage, and on December 18, it became the second to receive an emergency use authorization from the FDA. The vaccine has since been authorized by Canada, Israel, and the European Union.
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Moderna's vaccine uses messenger RNA (mRNA) to instruct the body to produce antibodies against the novel coronavirus. This is a new technique for vaccines, which has never been used before, but it would be easy to scale up.
The company had officially launched a 30,000-person phase 3 trial to test the vaccine's ability to prevent a COVID-19 infection on July 27. For the trial, participants in the treatment group received two 100-microgram doses of the vaccine, 28 days apart. During earlier trials, that dosage produced mild or moderate side effects, such as fatigue, chills, and headache, in all participants.
On November 16, Moderna announced the preliminary findings of the phase 3 trial, reporting that it appeared to be 94.5% effective at preventing COVID-19 infections. Based on the final results, released on November 30, the exact number is 94.1%.
Moderna said it will deliver 20 million doses to the U.S. before the end of the year and make an additional 85-100 million available to the nation in the first quarter of 2021. The first of those doses was administered on December 21.
Pfizer's RNA Vaccines (BNT162B1 & BNT162B2)
Pharma giant Pfizer had developed BNT162-01, an mRNA-based coronavirus vaccine, in partnership with German company BioNTech and Chinese drugmaker Fosun Pharma. On December 11, it became the first COVID-19 vaccine authorized for use in the U.S.
Pfizer shared early results on its late-stage trials on November 9, reporting that the vaccine appears to be 90% effective at preventing COVID-19 infections. Less than 10 days later, it updated that figure to 95%, adding that the vaccine was more than 94% effective in trial participants over the age of 65.
Pfizer submitted its request for an EUA to the FDA on November 20. The review process took several weeks, but as soon as the vaccine was authorized, Pfizer began the distribution process, with the first doses reaching healthcare workers and nursing home staff on December 14.
The U.K. issued its own emergency authorization for Pfizer's vaccine on December 2, becoming the first Western nation to approve a COVID-19 vaccine. The EU authorized the vaccine on December 21, and it's also been authorized or approved by Canada, Mexico, Switzerland, and numerous other nations.
Pfizer's goal is to produce more than 1.3 billion doses of the vaccine in 2021.
Oxford's Viral Vector Vaccine (ChAdOx1-S)
To create a viral vector vaccine, researchers from the University of Oxford and pharma company AstraZeneca added genetic material from the novel coronavirus's spike protein to a common cold virus (actually a chimpanzee adenovirus). The coronavirus genes should spark antibodies against COVID-19, while the harmless adenovirus lacks the tools to cause a real infection.
On November 23, Oxford shared interim trial data for two different dosing regimens tested in phase 3 trials. In one, the vaccine was 90% effective, and in the other, it was 62% effective, for an average efficacy of 70.4%. No one who received the vaccine developed a severe case of COVID-19.
On December 30, the U.K. and Argentina authorized the vaccine for use. India followed suit on January 3, and Mexico authorized the vaccine on January 4.
While not the first vaccine to receive authorization, it is cheaper than the ones produced by Pfizer and Moderna ($3-$4 per dose compared to $20-$37). It can be transported and stored at refrigerator temperatures, too, which could make it easier to distribute.
AstraZeneca says it could produce two billion doses of the vaccine in 2021.
Sinopharm's Inactivated Vaccine
Some vaccines provide protection against disease by introducing the body to an inactivated version of a virus or bacteria — that is, one that can no longer make a person sick, but can still prompt an immune response.
The first inactivated coronavirus vaccine to make it to phase 3 trials is co-developed by Chinese state-owned company Sinopharm and the Wuhan Institute of Biological Products.
In June, Sinopharm reported that the vaccine produced antibodies in every participant in a combined phase 1 and 2 trial. The following month, it launched a phase 3 trial in the United Arab Emirates (UAE), which is now ongoing.
For that trial, participants in the treatment group are receiving two doses of the vaccine, three weeks apart. In earlier trials, no serious adverse effects were reported.
Sinopharm's goal is to have the vaccine ready to enter the market by the end of 2020 or in early 2021.
On August 22, Chinese health officials announced via state-controlled media that the nation has begun inoculating high-risk residents with the vaccine on July 22.
On September 14, the UAE announced that it had also approved the vaccine for healthcare workers at high risk of contracting COVID-19.
Sinopharm's Other Inactivated Vaccine
Sinopharm is also collaborating on an inactivated coronavirus vaccine with the Beijing Institute of Biological Product.
A combined phase 1 and 2 trial of that vaccine, BBIBP-CorV, launched in April, and Sinopharm is now testing it on 5,000 people in a phase 3 trial in the United Arab Emirates.
On August 22, Chinese health officials announced via state-controlled media that the nation has begun inoculating high-risk residents with the vaccine on July 22.
On September 14, the UAE announced that it had approved the vaccine for healthcare workers at high risk of contracting COVID-19.
On December 30, Sinopharm announced that the vaccine had an efficacy rate of 79%, and China approved it for broad use the same day.
Sinovac Biotech's Inactivated Vaccine (CoronaVac)
Chinese biotech firm SinoVac has also developed an inactivated coronavirus vaccine — CoronaVac — and in August, the company secured an emergency use approval from the nation to begin dosing high-risk populations with the vaccine.
The path to that started in April, when the firm launched a combined phase 1 and 2 trial of the vaccine, and according to the preliminary results published in June, it prompted the production of neutralizing antibodies in more than 90% of participants within 14 days.
In mid-July, SinoVac launched a phase 3 CoronaVac trial involving 9,000 doctors and healthcare workers in Brazil. For that trial, participants in the treatment group received two doses of the vaccine, 14 days apart. None of the participants in the earlier trials experienced any severe adverse reactions.
On December 21, the Wall Street Journal reported that the vaccine was at least 50% effective in the Brazilian trials, according to people involved in them. On January 7, Brazilian officials themselves announced that the efficacy was 78%, but soon after, researchers at the institute running the trial said it was just 50.4% effective.
SinoVac hasn't said when it expects CoronaVac to be available to the public, but it is ready to manufacture 100 million doses.
The Tuberculosis Vaccine (Bacillus Calmette-Guerin)
One of the COVID-19 vaccines currently in phase 3 trials is not like the others — because it was actually developed a hundred years ago to protect against an entirely different disease.
Every year, doctors use the Bacillus Calmette-Guerin (BCG) vaccine to inoculate more than a million children against tuberculosis. But some researchers suspect that the vaccine may have an "off target" effect: protection against COVID-19.
Murdoch Children's Research Institute is one of several groups putting that theory to the test.
In March, it launched a phase 3 trial during which 10,000 healthcare workers will receive either the BCG vaccine or a placebo. The researchers will then follow up to see whether the vaccine appears to prevent or decrease the severity of coronavirus infections.
CanSino's Viral Vector Vaccine (Ad5-nCoV)
Chinese company CanSino Biologics's candidate is another unique addition to this list of coronavirus vaccines because it had already received limited government approval before reaching the phase 3 trial stage.
On June 25, CanSino announced that it had received special approval to distribute Ad5-nCoV to members of China's military for one year.
The following month, the company reported that the vaccine prompted the creation of both antibodies and T cells in most phase 2 trial participants. However, it didn't appear as effective in people who already had immunity to the harmless cold virus it uses to transport the coronavirus's genetic material.
In an early trial, the majority of patients (81%) had at least one adverse effect, including pain at the injection site (54%), fever (46%), fatigue (44%), headache (39%), muscle pain (17%), and vomiting or diarrhea (13%). The study, published in The Lancet, reported, "Most adverse reactions were mild or moderate in severity," but a handful of participants (mostly in the high-dose group) did report severe fever (over 101.3 F), fatigue, or muscle or joint pain.
If the vaccine proves effective in those trials, CanSino is ready to produce up to 200 million doses of it annually starting in early 2021.
Russia's Viral Vector Vaccine (Sputnik V)
Another outlier on this list is a viral vector vaccine developed by Russia's Gamaleya Research Institute.
After less than two months of human testing, President Vladimir Putin announced on August 11 that the vaccine, officially Gam-Covid-Vac Lyo but called "Sputnik V," had been approved, with mass vaccinations expected to begin in October.
Russia had yet to release the detailed results of the vaccine's phase 1 or 2 trials at the time of the announcement, and a small phase 3 trial was ongoing, leading many in the scientific community to question the vaccine's efficacy and safety.
On August 20, Russia said the vaccine's approval was actually a "conditional registration certificate" and announced plans to expand the phase 3 trial from 2,000 volunteers to 40,000.
A few weeks later, on September 4, the Gamaleya researchers did publish the data from their phase 1 and 2 trials in the Lancet, reporting that it produced only mild side effects and prompted an antibody response.
On September 7, Enrico Bucci, an adjunct professor in systems biology at Temple University, published an open letter calling into question the reliability of Russia's data. An additional 37 scientists have since signed it.
On November 24, the developers reported a second interim analysis of their trial, which had by then enrolled more than 18,000 people. Based on 39 cases of COVID-19, the vaccine was 91.4% effective at preventing infection.
Johnson & Johnson’s Adenovirus Vaccine (JNJ-78436735)
On September 23, healthcare giant Johnson & Johnson announced that its COVID-19 vaccine had reached the critical phase 3 stage of human testing, making it the fourth vaccine to hit the milestone in the U.S.
Johnson & Johnson's vaccine is designed to deliver protection with just one shot, not two (though that may change). It can also be stored in a refrigerator, unlike the vaccines developed by Moderna and Pfizer, which need to be stored at below-freezing temperatures. That could make it easier to distribute.
Johnson & Johnson's phase 3 trial hit a snag on October 12 when the company announced a study pause due to a patient exhibiting an "unexplained illness". The company was cleared to resume the trial on October 23.
On November 16, the company announced plans to launch another phase 3 trial to test the efficacy of a two-dose regimen, and while the initial plan was to enroll 60,000 volunteers across three continents in the first phase 3 trial, the company capped enrollment at 45,000 in December.
Johnson & Johnson expects to have results from its phase 3 trial in late January and aims to produce a billion doses of its vaccine in 2021.
Novavax's Recombinant Vaccine (NVXCoV2373)
Maryland-based Novavax has yet to successfully bring a vaccine to market, but on September 24, the company joined the ranks of those to launch a phase 3 trial of a COVID-19 vaccine.
Novavax's vaccine prompts an immune response by introducing the body to a coronavirus protein housed within microscopic particles — the same tried-and-true approach taken by existing vaccines for HPV and shingles.
In monkey studies, the vaccine provided protection against COVID-19, and in small human trials, volunteers exhibited high levels of antibodies after receiving the vaccine.
Novavax launched a 15,000-person phase 3 trial in the U.K. in September. A 30,000-person phase 3 trial in the U.S. followed in December. Half the volunteers are receiving two doses of the vaccine, delivered three weeks apart, while the others are receiving a placebo.
If the vaccine proves effective and secures regulatory approval, Novavax expects to be able to produce 2 billion doses of it annually by mid-2021.
The Vector Institute's Peptide-Based Vaccine (EpiVacCorona)
On October 14, Russian President Vladimir Putin announced the approval of the nation's second COVID-19 vaccine: EpiVacCorona.
Siberia's Vector Institute developed the vaccine, which contains small bits of proteins from the coronavirus called peptides. The vaccine has yet to be put to the test in a phase 3 trial, and the results of earlier-stage human trials have yet to be published.
In November, a phase 3 trial expected to include 30,000 people kicked off. On December 15, the Russian news agency Interfax reported that 1,438 trial participants had received the vaccine.
Anhui Zhifei Longcom Biopharmaceutical's Subunit Vaccine
Biopharmaceutical company Anhui Zhifei Longcom has partnered with the Chinese Academy of Medical Sciences to develop a recombinant subunit vaccine candidate for COVID-19.
“The vaccine involves protein so it doesn’t require a high biosafety level production facility (as needed for inactivated vaccines)," CAS researcher Yan Jinghua explained. "The production process is very safe, which guarantees accessibility to the vaccine."
On November 20, the group launched a phase 3 trial of the vaccine in China. Trials in Uzbekistan, Indonesia, Pakistan, and Ecuador are expected to follow shortly, with the goal of enrolling 29,000 adults in the trial.
CureVac's mRNA Vaccine (CVnCoV)
On December 14, German biopharmaceutical company CureVac launched a phase 3 trial for its mRNA vaccine candidate, CVnCoV. That trial is expected to involve 36,500 participants in Germany.
Unlike the mRNA vaccines developed by Pfizer and Moderna, CureVac's candidate wouldn't need to be stored at freezing temperatures — it remains stable at 41 degrees Fahrenheit. That could make it easier to distribute if late-stage trials go well and the vaccine is approved.
The company has also worked with Tesla to develop "mini-factories" that would allow it to manufacture the vaccine across the globe. That could both increase the supply of the vaccine and make it easier to distribute.
India's Inactivated Vaccine (Covaxin)
The Indian Council of Medical Research, India's National Institute of Virology, and Indian company Bharat Biotech have collaborated on an inactivated COVID-19 vaccine called Covaxin.
In June, the vaccine became the first Indian-produced candidate to reach human trials. Phase 3 trials began in October, and India authorized the vaccine on January 3, despite the fact that the results of those trials was still pending.
Zydus Cadila's DNA-Based Vaccine (ZyCoV-D)
India's Zydus Cadila has developed a DNA-based COVID-19 vaccine that is delivered via a skin patch instead of a needle. The company kicked off phase 2 trials of the vaccine in August, and on January 3, it secured approval to begin a 30,000-person phase 3 trial in India.
Zydus Cadila's chairman Pankaj Patel says the goal is to have the vaccine ready for distribution by March 2021.
Kazakhstan's Inactivated Vaccine (QazCovid-in️)
Researchers at Kazakhstan's Research Institute for Biological Safety Problems have developed an inactivated COVID-19 vaccine that was shown to be safe and capable of prompting an immune response in phase 2 trials.
On December 19, the researchers kicked off a phase 3 trial of the vaccine involving 3,000 volunteers. Their hope is to secure approval in March 2021.
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