The development of a vaccine typically spans from 10 to 15 years but the urgency of COVID-19 has sped up the process to have multiple vaccine candidates viable in just a year. Of those candidates, Pfizer and Moderna’s candidates have been granted emergency authorization by the U.S. Food and Drug Administration.
Aside from those two, over 60 vaccines are going through a three-stage clinical trial process, with some of those trial phases being run simultaneously.
Phase one trials are meant to evaluate the safety of a vaccine and whether it triggers an immune response in a limited group. Phase two evaluates the efficacy of the vaccine by broadening the testing pool to include vulnerable individuals. While phase three evaluates the vaccine’s safety and efficacy by testing thousands of individuals from different groups.
Various types of vaccines are being developed to protect against COVID-19.
A nucleic-acid vaccine uses parts of a virus’s genetic material to trigger the production of antibodies. Another type uses an inactive virus to provoke an immune response while a viral vector vaccine introduces DNA from the virus to an unrelated germ. A protein vaccine is made from synthesized virus proteins.
Here are all the COVID-19 vaccine candidates that have accomplished or are currently conducting phase three trials.
COVID-19 Vaccine Candidates
Johnson & Johnson
JNJ-78436735, a single-dose vector vaccine, is developed by one of the largest multinational corporations in the world. It has not yet been approved for use.
Clinical trial status: Johnson & Johnson launched its phase three trial called “ENSEMBLE” last September 23, 2020. The trial was fully enrolled with 45,000 individuals from different countries including “significant representation” from older or vulnerable populations by December 17.
On January 29, 2021, Johnson & Johnson released results from their phase three trial showing their single-shot vaccine candidate had met all primary and key secondary endpoints.
A second phase three trial testing a two-dose regimen of its vaccine candidate was launched last November 15. It intends to study the effects of a second dose of the vaccine.
Efficacy and safety: A study published in Nature confirmed that the vaccine generated neutralizing antibodies in monkeys. The single-dose was also able to provide “complete or near-complete” protection.
The New England Journal of Medicine reported phase two results showing that 90% of trial participants developed antibodies in 29 days while the remaining participants did so by 57 days.
Phase three trials were paused on October 12 to conduct an independent safety review after a participant contracted an unexplained illness. Johnson & Johnson assured that illnesses and accidents can only be expected in large clinical trials with study pauses being the norm. The trial resumed on October 23.
Johnson & Johnson published results from their phase three trial showing the vaccine candidate to be 66% effective in preventing mild and severe COVID-19 cases, 28 days after vaccination.
Distribution: Johnson & Johnson initially committed to producing 12 million doses by the end of February and 100 million by the end of June. However, it was reported on January 13 that the company is at least 2 months behind schedule.
Novavax
NVX-CoV2373, a protein vaccine, is developed by a biotechnology company based in Maryland. It has not yet been approved for use.
Clinical trial status: Novavax launched its phase three trial in the United Kingdom last September 24. The trial was fully enrolled with 10,000 participants including those with underlying conditions on November 30.
A second phase three trial including 30,000 participants from the U.S. and Mexico was launched on December 28. Trials have been delayed due to manufacturing issues.
Efficacy and safety: A study published in the New England Journal of Medicine confirmed the vaccine’s ability to produce COVID-19 antibodies and T cells.
Novavax released preliminary phase three results on January 28 showing 89.3% efficacy for its vaccine. However, preliminary results from its trial in South Africa showed a drop to 49.4% efficacy against the South African COVID-19 variant. They are currently developing a booster vaccine to better protect against different virus variants.
Moderna Therapeutics
mRNA-1273, a nucleic-acid vaccine, is being developed by a biotech company based in Massachusetts in partnership with the National Institute of Health. It was granted emergency approval by the FDA last December 18. It has also been approved for use in the European Union, Canada, the U.K., and Israel.
Clinical trial status: Moderna launched its phase three trial with 30,000 U.S. participants last July. The company will also conduct clinical trials to evaluate the vaccine’s safety for children and cancer patients alongside establishing a “pregnancy registry”.
They will also be testing a booster vaccine to be administered a year after the initial doses.
Efficacy and safety: The FDA’s analysis of Moderna’s phase three study confirms the vaccine’s 94.1% efficacy rate for mild cases and 100% efficacy rate for severe cases after two doses.
Although unverified, Moderna claims the vaccine remains effective against both the U.K. and South African COVID-19 variants. The company will be developing a booster vaccine to protect against different virus variants.
Distribution: Moderna estimates a total of 20 million doses to be shipped across the U.S. by the end of 2021. They have already started shipping the first 5.9 million doses. The company is on track to deliver 500 million doses globally per year starting 2021.
Pfizer
BNT162b2, a nucleic-acid vaccine, is developed by one of the world’s largest pharmaceutical companies in partnership with the German biotech company BioNTech. It was granted emergency approval by the FDA last December 11. It has also been approved for use in the U.K., Canada, and the European Union.
Clinical trial status: Pfizer’s phase three trial was launched last July and completed on November 18. The trial enrolled a diverse population and expanded to include 44,000 participants across various countries.
Efficacy and safety: Results from Pfizer’s phase three trial showed the vaccine to have 95% efficacy. The FDA’s analysis of the phase three study confirmed this.
However, there have been a few cases of severe allergic reactions to the vaccine. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, states that this is not outside the norm.
Distribution: Pfizer and BioNTech have committed to providing 200 million doses to the U.S. by July 31, 2021. The first vaccinations have already been administered to U.S. healthcare workers.
Pfizer estimated a total of 1.3 billion doses to be produced by the end of 2021.
Bharat Biotech
COVAXIN, an inactivated vaccine, is developed by an Indian biotechnology company in partnership with the Indian Council of Medical Research and the National Institute of Virology. It has been authorized for emergency use in India.
Clinical trial status: Bharat Biotech launched its phase three trial with 26,000 participants last November 26.
Efficacy and safety: Unverified results from phase one trials claim the vaccine’s ability to produce antibodies in monkeys and 90% of human participants from early vaccine trials.
Results from their phase three trial have not yet been published. However, the biotech company has stated that it “has generated excellent safety data with robust immune responses.”
Distribution: The company has yet to make any distribution commitments though it has signed an agreement to sell COVAXIN in Brazil.
Sinopharm
This unnamed inactivated vaccine is developed by a Chinese state-run pharmaceutical company in partnership with the Wuhan Institute of Biological Products. It has been approved for use in China, Bahrain, and the United Arab Emirates among other countries.
Clinical trial status: Sinopharm launched its phase three trial with 15,000 UAE participants last July. They will also conduct trials in Peru and Bahrain.
Efficacy and safety: Preliminary findings published in the Journal of the American Medical Association evidenced the vaccine’s ability to trigger an antibody response.
Sinopharm announced the vaccine to have 79% efficacy but has not released data to verify this. An interim analysis from the UAE claims the vaccine to be 86% effective in preventing COVID-19 with no serious risks.
Distribution: The company has yet to make any distribution commitments though it has signed an agreement to sell the vaccine in Hungary.
Sinovac
Coronavac, an inactivated vaccine, is developed by a Chinese biopharmaceutical company in partnership with Brazilian research center Butantan. It has been approved for limited use in China and India.
Clinical trial status: Sinovac launched its phase three trial with 9,000 healthcare professionals in Brazil last July in concurrence with its phase three trial in Indonesia.
Efficacy and safety: Results from its phase three trials show the efficacy of 50.4% for the vaccine, only just above the 50% minimum requirement of the World Health Organization. Preliminary results from Sinovac’s early trials revealed the vaccine is only able to produce a moderate immune response.
University of Oxford
ChAdOx1 nCoV-19, a viral vector vaccine, is developed by the U.K. university in partnership with biopharmaceutical company AstraZeneca. It has been approved for use in the United Kingdom, India, Argentina, and other countries.
Clinical trial status: The phase three trial of the AstraZeneca-Oxford vaccine intends to recruit approximately 50,00 volunteers in Brazil, the U.K., the United States, and South Africa. The trials were paused as an adverse reaction in one participant prompted a safety review. Independent regulators conducted an investigation and the trial in U.KBrazil, South Africa, and India resumed afterward while the U.S. resumed trials a month later.
Efficacy and safety: Results from an interim analysis of Oxford’s phase three trials showed that the vaccine is safe and is 70.4% effective in preventing COVID-19 after two doses and conversely 64.1% effective after one standard does. The preliminary results from phase two trials have shown that across all adult age groups, the vaccine produces a strong immune response to the virus. Distribution: Oxford and AstraZeneca expect to produce approximately three billion doses in 2021. Project members will seek an “emergency use listing” from the World Health Organization to allow the candidate to set up in lower-income countries.
The Gamalaya National Center of Epidemiology and Microbiology
Sputnik V, a viral vector vaccine, is developed by a Russian research institution in partnership with the Russian Direct Investment Fund. It has been approved for use in Russia, Belarus, Argentina, Venezuela, and other countries.
Clinical trial status: Gamelaya announced phase three trial results showed the vaccine to have an efficacy of 94.1%. The trial reportedly had over 22,000 participants though results have yet to be publicly published.
Efficacy and safety: The vaccine was found to have a 92% efficacy rate based on phase three trial interim results. However, the report was only based on 20 cases which are not enough to conclude from.
Murdoch Children’s Research Institute
This Bacillus Calmette-Guerin (BCG) vaccine is being developed by the largest child health research institute in Australia in partnership with the University of Melbourne. It has not yet been approved for use.
Clinical trials status: The Murdoch Children’s Research Institute aims to have 10,000 health workers participate in a series of randomized controlled trials that started in April. The World Health Organization noted that there is no current evidence that supports the BCG vaccine can protect people against infections with coronavirus.
CanSino Biologics
Ad5-nCoV, a viral vector vaccine, is developed by a Chinese biopharmaceutical company. Despite it still being in phase two of its trial, CanSino’s vaccine was the first company to receive limited approval to use its vaccine in people. According to the Chinese government, the vaccine’s use will be limited to the military for one year.
Clinical trial status: For its phase three trials, Cansino stated that it recruited approximately 20,000 participants from Pakistan, Russia, Mexico, Chile. The first phase three trial of Ad5-nCoV was launched on August 15 by Russian biopharmaceutical company Petrovax.
Efficacy and safety: The vaccine was shown to produce significant immune responses from a single dose based on results from the vaccine’s phase two trials. It also showed that there were no serious adverse reactions.
Vector Institute
EpiVacCorona, a protein vaccine, is developed by a Russian biotechnology institute. It has been granted regulatory approval by Russia despite there being no record of it entering phase three of its clinical trials. This vaccine is the second vaccine candidate to be approved by Russia without published evidence on its safety and efficacy.
Clinical trial status: According to Russian state news agency TASS, no adverse reactions were observed among the trial’s 2,000 volunteers.
CureVac
CVnCoV, an mRNA vaccine, is being developed by a German biopharmaceutical company in partnership with Bayer. It has not yet been approved for use.
Clinical trial status: CureVac began enrolling participants in a phase 2b/3 study last December 14. The trial aims to include 35,000 participants from Europe and Latin America. They are also conducting a phase three trial for healthcare workers in Germany.
Efficacy and safety: Preliminary results have shown the vaccine to incite a strong antibody and T-cell response in rhesus macaques.
Zydus Cadila
ZyCoV-D, a DNA-based vaccine, is developed by an Indian pharmaceutical company. It has not yet been approved for use.
Clinical trial status: Zydus Cadila received approval to launch their phase three trials with 30,000 participants on January 3.
Efficacy and safety: A combined phase one/two trial of the vaccine evidenced its safety and ability to trigger an immune response. However, no data was released to back these claims.
Anhui Zhifei
ZF2001, a subunit vaccine, is developed by a Chinese biopharmaceutical company in partnership with the Institute of Microbiology at the Chinese Academy of Studies. It has not yet been approved for use.
Clinical trial status: Chinese health officials announced the vaccine’s phase three trials with 29,000 participants from China, Indonesia, Pakistan, and Ecuador last November.
Research Institute for Biological Safety Problems
QazCovid-in, an inactivated vaccine, is developed by a Kazakh research institute. It was granted temporary registration in Kazakhstan.
Clinical trials status: The institute launched its phase three trial with 3,000 participants in December. The vaccine was granted temporary registration despite its lack of phase three trial results.
Institute of Medical Biology at the Chinese Academy of Medical Sciences
This unnamed inactivated vaccine is developed by a Chinese research institute. It has not yet been approved for use.
Clinical trial status: Phase three trials with 34,020 participants from Malaysia and Brazil were launched in December.
Efficacy and safety: Preliminary results from the vaccine’s phase one trial showed the vaccine’s ability to trigger an immune response with no severe side-effects.
COVID-19 Vaccine Protocols
President Joe Biden announced on January 21 a $20-billion national vaccination program. Rollout plans will vary per State, though Biden encourages all to prioritize frontline workers and aging populations. Community vaccination centers and mobile vaccination units will be set up as part of Biden’s vaccination program. Free vaccinations for everyone in the U.S., regardless of immigration status, will also be afforded.
Given that there is an urgent need to vaccinate the majority of the population against COVID-19, it is all the more important to be aware of and follow the specific laws and guidelines regarding sharps.
Sharps Disposal
Medical sharps refer to objects that can pierce the skin, such as needles, syringes, and lancets. It is necessary to dispose of these properly as they have the potential to infect other individuals.
The FDA recommends this 2-step process for sharps disposal:
- Place all used sharps in an appropriate sharps disposal container. The container should only be ¾ filled and tightly sealed afterward.
Dispose of the sharps container in accordance with community guidelines. Disposal may be arranged through sharps container removal or sharps pickup. Programs facilitating mailback sharps container may also be used.