UPDATE: SARS-CoV-2 vaccines to prevent COVID-19 - roundup of the front runners
By January 2021, the World Health Organization (WHO) was reporting that 63 SARS-CoV-2 vaccines had made it into clinical development for the prevention of COVID-19. Many more were also in preclinical development.
Although still investigational products, several vaccine candidates have been approved for emergency use in different countries including vaccines developed by AstraZeneca and the University of Oxford, Moderna, Pfizer and BioNtech, Sinopharm and the Beijing Institute of Biological Products, and Sinovac.
A number of different types of SARS-CoV-2 vaccines are being investigated, including traditional designs that contain inactivated virus. Other approaches are also being employed, including non-replicating adenoviral vector vaccines and mRNA (ribonucleic acid)-based vaccines. Adenoviral vector vaccines and mRNA-based vaccines have not previously been marketed for use in people.
- Non-replicating viral vector vaccines
- AZD1222 (ChAdOx1-S, ChAdOx-1 nCoV-19) - University of Oxford / AstraZeneca
- Ad5-nCoV - CanSino Biological / Beijing Institute of Biotechnology, Academy of Military Medical Science
- Sputnik V (rAd26-S+rAd5-S, Gam-COVID-Vav) - Gamaleya Research Institute
- Ad26.COV2.S (JNJ-78436735, Ad26COVS1) - Janssen Pharmaceuticals
- mRNA-based vaccines
- Inactivated virus-based vaccines
- Vero-cell derived inactivated COVID-19 vaccines - Sinopharm / Wuhan Institute of Biological Products / Beijing Institute of Biological Products
- CoronaVac (PiCoVacc) - Sinovac
- Protein subunit vaccines
- NVX-CoV2373 - Novavax
- DNA Vaccine
- INO-4800 - Inovio Pharmaceuticals
Non-replicating viral vector vaccines
AZD1222 (ChAdOx1-S, ChAdOx-1 nCoV-19) - University of Oxford / AstraZeneca
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Approved by the UK Medicine and Healthcare products Regulatory Agency (MHRA) for emergency supply
On 30 December 2020, the Oxford / AstraZeneca vaccine - AZD1222 - was approved for emergency use in the UK by the MHRA and the first patients received their first dose of the vaccine just days later. The vaccine has been approved for use in patients 18 years of age and older and is to be administered in two doses, with the second dose given 4-12 weeks after the first. A key advantage of this vaccine is that it can be stored in a normal refrigerator, unlike the Pfizer vaccine that has to be stored at between -112°F and -76°F (-80°C and -60°C).
Phase III development of AZD1222 began in the US in August 2020, following the initiation of a phase II/III trial in the UK in May. An interim analysis of data from these trials has reported to show that the vaccine is safe and effective against symptomatic COVID-19.
About AZD1222
AZD1222 uses a recombinant viral vector called ChAdOx1, which is based on a weakened version of an adenovirus (common cold virus) that causes infections in chimpanzees. ChAdOx1 contains the genetic material of the spike protein from SARS-CoV-2. After vaccination the surface spike protein is produced, priming the immune system to fight off the COVID-19-causing virus. ChAdOx1 was chosen for its ability to induce a strong immune response and because it doesn’t replicate, so it is not able to cause an ongoing infection.
AZD1222 was developed by the Jenner Institute and it’s spin-out company, Vaccitech. The University of Oxford, which worked with the Oxford Vaccine Group, has also been involved in the vaccine’s development.
The University has entered into a collaboration with AstraZeneca to develop and distribute the vaccine globally. AstraZeneca has since engaged with other organizations including Oxford Biomedica, the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organization (WHO) to support the manufacture and distribution of the vaccine. AstraZeneca reported on May 21, 2020 that it had received $US1bn from the US Biomedical Advanced Research and Development Authority (BARDA) to develop, produce and deliver the vaccine.
Ad5-nCoV - CanSino Biological / Beijing Institute of Biotechnology, Academy of Military Medical Science
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Phase III development
In January 2021, Pakistan officials announced they planned to seek regulatory approval of the CanSino coronavirus vaccine, which has been undergoing phase III development in Pakistan and at other sites worldwide since September 2020. A single shot of Ad5-nCoV is being evaluated.
Another smaller phase III trial testing a low-dose of Ad5-nCoV (5E10 vp, 5 x 1010 viral particles) was also initiated in Russia in September 2020.
A phase II trial of Ad5-nCoV concluded that low-dose Ad5-nCoV was safe and induced a significant immune response in most of the volunteers after one dose. At day 28, a significant neutralizing antibody response to live SARS-CoV-2, with a geometric mean titre (GMT) of 19.6 (95 percent CI 16.8-22.7), was observed in study volunteers. Vaccination with low-dose Ad5-nCoV also induced seroconversion of the neutralizing antibodies in 47 percent of recipients. Specific T-cell responses were also observed in 88 percent of the volunteers in this group. A higher dose version (1E11 vp, 1 x 1011 viral particles) of the vaccine was also tested, but severe adverse reactions were reported in 9 percent of volunteers who received the higher dose, compared with only 1 percent in the lower-dose (5E10 vp) group.
One of the concerns with adenoviral vector vaccines is that many people may have already been infected with the cold virus that is used as the vector in the vaccine and this may lead to a weaker antibody response to the vaccine. It is also possible that the immune response to the vaccine, particularly the humoral immune response, could be reduced in older people.
About Ad5-nCoV
Like AZD1222, Ad5-nCoV uses a non-replicating adenoviral vector and expresses the spike glycoprotein of SARS-CoV-2. It is being developed by CanSino Biological and the Beijing Institute of Biotechnology.
Cansino had entered into a partnership with the National Research Council of Canada to test Ad5-nCoV, but in August 2020 it was reported that Canadian trials would not go ahead because Chinese customs would not allow the vaccine to be exported.
In May 2020, CanSino partnered with Precision NanoSystems in Canada to develop a separate mRNA lipid nanoparticle (LNP) vaccine against COVID-19.
Sputnik V (rAd26-S+rAd5-S, Gam-COVID-Vac) - Gamaleya Research Institute
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Granted limited approval in Russia in August 2020 and phase III development ongoing
In August 2020, a vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, Russia, was approved for use in a limited number of vulnerable people including healthcare workers and the elderly. Limited approval was granted despite the vaccine only being tested in 76 people.
A phase III trial of the two-dose vaccine is currently underway in Russia and Belarus and is expected to be completed in May 2021. Other phase III trials are also planned at more sites outside of Russia.
Ad26.COV2.S (JNJ-78436735, Ad26COVS1) - Janssen Pharmaceuticals
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Phase III development
In September 2020, the phase III ENSEMBLE trial of Ad26.COV2.S began recruiting volunteers at a number of sites worldwide. It is testing one dose of the vaccine. The trial was briefly paused in the US in October 2020, but recruitment was able to resume shortly after. A second, large phase III trial, called ENSEMBLE 2, was initiated in November 2020 and is testing a two-dose regime of the vaccine. The trials are being conducted at sites in the US, UK, Europe and in other locations worldwide.
Phase III results are expected in late January 2021, which are expected to be used to support emergency approval of the vaccine in the US. The roll out of the vaccine is likely to be delayed, however, due to issues manufacturing the vaccine.
About Ad26COVS1
Ad26.COV2.S is an adenovirus serotype 26 (Ad26) vector-based vaccine which expresses the SARS-CoV-2 spike (S) protein. It is being developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
The company has agreed in principle to collaborate with the UK Government on the vaccine's phase III trial in return for supplies of the vaccine if it is approved. It has also received US$1bn from BARDA in the US for the manufacture and supply of the vaccine.
mRNA-based vaccines
mRNA-1273 - Moderna / National Institute of Allergy and Infectious Diseases
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Approved for emergency use in the US, Canada, Israel, Europe, the UK, Switzerland and the EU
On 18 December the US Food and Drug Administration (FDA) approved mRNA-1273 for emergency use in people 18 years of age and older, after results suggested the vaccine efficacy rate is 94.1%. The two-dose vaccine has since been approved for emergency use in Canada, Israel, Europe, the UK and Switzerland.
About mRNA-1273
mRNA-1273 is a mRNA-based vaccine that is being developed in the US by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID). Development of this vaccine is also being funded by a grant from BARDA.
mRNA-based vaccines take a section of mRNA, which codes for a protein on the surface of a virus, and inserts it into a virus or liposome. When the vaccine is injected, the mRNA integrates into cells, the target protein is manufactured, and the immune system reacts and attacks any virus it encounters. mRNA-1273 specifically encodes for the full-length, pre-fusion stabilized S (spike) protein of SARS-CoV-2.
This vaccine needs to be kept frozen between -13°F and 5°F (-25°C and -15°C), but can be stored in a refrigerator for up to 30 days at between 36°F and 46°F (2°C and 8°C).
Moderna has entered into a 10-year agreement with Lonza for the manufacture of mRNA-1273.
BNT162b2 (modRNA, Comirnaty) - BioNTech / Fosun Pharma/ Pfizer
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Approved for emergency use in the UK, Canada, the US, Switzerland and the EU
On 2 December 2020, BNT162b2 was approved for use in the UK following interim results from a phase III trial suggesting two-doses of BNT162b2 30 µg were 95% effective in patients 16 years of age and older. The vaccine has since been approved in Canada, the US, Switzerland and the EU.
About BNT162b2
BNT162b2 is one of four mRNA-based vaccine candidates evaluated as part of BioNTech’s BNT162 COVID-19 vaccine program. All of the vaccines make use of the company’s LNP mRNA vaccine platforms.
The four candidates have different mRNA formats and targets and BNT162b2 specifically encodes an optimized SARS-CoVo2 full length spike (S) glycoprotein.
The vaccine needs to be stored at -94°F (-70°C), but can be kept in the refrigerator for up to 5 days at 36-46°F (2-8°C).
BioNTech is a German biotech company which is collaborating with Fosun Pharma in China and Pfizer outside of China to develop a vaccine.
CVnCoV - CureVac
- Phase II/III development
In December 2020, the phase II part (called HERALD) of a phase II/II trial of CVnCoV was initiated in Europe and Latin America. Participants will receive two doses of the 12 µg strength of the vaccine, which selected following the results of a phase I trial.
About CVnCoV
CVnCov is an mRNA-based COVID-19 vaccine being developed by the German biotechnology company CureVac. The vaccine can remain stable at standard refrigerator temperatures for at least three months and for 24 hours at room temperature.
In January 2021, Bayer signed a collaboration and services agreement with CureVac covering CVnCoV. Bayer will assist CureVac in the development, approval and supply of the vaccine. CureVac is working to expand its network of partners to develop the vaccine and has also entered into manufacturing related agreements with Wacker, Fareva and others.
Inactivated virus-based vaccines
Vero-cell derived inactivated COVID-19 vaccines - Sinopharm / Wuhan Institute of Biological Products / Beijing Institute of Biological Products
- Two vero-cell derived inactivated COVID-19 vaccines are being developed by Sinopharm
- The vero-cell derived inactivated COVID-19 vaccine developed by Sinopharm and the Beijing Institute of Biological Products was approved for use in the United Arab Emirates (UAE), Bahrain and China in December 2020
- Both vaccines were previously approved for urgent use in China
On 9 December 2020, the vero-cell derived inactivated COVID-19 vaccine developed by Sinopharm and the Beijing Institute of Biological Products was approved for use in the United Arab Emirates (UAE), having already been granted emergency approval for use in front-line workers in September 2020. The approval was based on results indicating the vaccine is 86% effective against COVID-19 infection. Since then the vaccine has also been approved in Bahrain and China.
Sinopharm had previously reported that it expects it will take more than a year to complete phase III development of the vaccine once it had been initiated.
About vero-cell derived inactivated COVID-19 vaccines
Two vero-cell derived inactivated COVID-19 vaccines have been developed by the China National Biotech Group (CNBG), the vaccine and bioscience subsidiary of Sinopharm Group (China National Pharmaceutical Group). The Wuhan Institute of Biological Products and Beijing Institute of Biological Products, which are part of Sinopharm, have also been involved in their development, as has the Wuhan Institute of Virology, a part of the Chinese Academy of Sciences.
CoronaVac (PiCoVacc) - Sinovac
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Approved for emergency use in China, Turkey and Indonesia
On 13 December 2021, CoronaVac was approved for emergency use in Turkey, with vaccinations set to begin the following day. It has also been granted approval for emergency in Indonesia and China
Results for phase III trials, which are being conducted in Turkey, Brazil, Indonesia and at other sites, are reported to have produced varying results. This has created some uncertainty regarding the effectiveness of the vaccine. Results from a large study in Brazil suggest the vaccine may only be just over 50% effective at preventing symptomatic COVID-19 infection, while other results suggest its efficacy rate could be as high as 65% or 91%, but these results were from very small trials.
About CoronaVac
CoronaVac is a purified inactivated SARS-CoV-2 virus vaccine candidate (PiCoVacc) being developed by Sinovac Biotech in China. Sinovac has entered into two agreements with Bio Farma in Indonesia covering CoronaVac.
Protein subunit vaccines
NVX-CoV2373 - Novavax
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Phase III development
Phase III development of NVX-CoV2372 began in the UK in September 2020, and in the US and Mexico in December 2020 (PREVENT-19 trial).
On August 17, 2020 a phase II trial of NVX-CoV2373 containing Novavax’s saponin-based Matrix-M adjuvant began in South Africa. The trial is being conducted in HIV negative and positive volunteers and results are expected in early 2021.
About NVX-CoV2373
NVX-CoV2373 is a vaccine being developed by Novavax, a biotechnology company with sites in the US and Sweden. The vaccine makes use of Novavax’s recombinant nanoparticle technology to generate antigen derived from the spike protein of SARS-CoV-2. It contains Novavax’s saponin-based Matrix-M adjuvant, which is designed to enhance the immune response generated by the vaccine.
In May 2020, Novavax reported that the CEPI will invest up to $US384mil on top of the $US4mil it has already invested to further the development of NVX-CoV2373. In total, Novavax has secured $US2bn in funding for its COVID-19 vaccine.
On September 15, 2020, Novavax reported that it has entered into a manufacturing agreement with Serum Institute of India, which will increase its production capacity for NVX-CoV2373 to over 2 billion doses annually. It has also entered into a number of other manufacturing agreements.
DNA Vaccines
INO-4800 - Inovio Pharmaceuticals
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Phase II/III development
The phase II segment of a phase II/III trial of INO-4800 was initiated in the US in November 2020. The trial is called INNOVATE and is being funded by the US Department of Defence (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defence (JPEO-CBRND) in collaboration with the Office of the Assistant Secretary of Defence for Health Affairs (OASD (HA)) and the Defence Health Agency (DHA). Two different doses of the two-dose vaccine will be evaluated. The phase III segment of the trial is on hold until Inovio has answered FDA questions about the device used to deliver the vaccine.
INO-4800 entered phase I/II development in Korea in July 2020. Results from a phase I study showed that all of the 38 participants had an immune response to the vaccine.
About INO-4800
INO-4800 is a synthetic DNA-based vaccine that targets the spike protein of SARS-CoV-2. It is being developed by Inovio Pharmaceuticals using its DNA medicine platform.
Unlike other vaccines that are administered via intramuscular injection, this vaccine is administered via intradermal injection followed by electroporation using the CELLECTRA 2000 device. It also does not need to be kept frozen during transport or storage.
Inovio has entered into a number of collaborations and is receiving funding to further the development of INO-4800, including $US17.2mil in funding that it has received from CEPI. Invovio is working with Beijing Advaccine in China and the International Vaccine Institute in South Korea. It is also working with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Australia, as well as other organizations.
In September 2020, Inovio partnered with Thermo Fisher for the manufacture of INO-4800. Thermo Fisher is one of a number of organizations involved in the manufacture of the vaccine. Invivo is planning to have 100 million doses of the vaccine manufactured in 2021.
Research must continue for SARS-CoV-2 vaccines
Although much progress has been made in recent months and people have started to be vaccinated in a number of countries, there are still a still questions regarding these vaccines that need to be answered including:
- What level of immune response to a vaccine do we need to confer immunity?
- How long will a vaccine provide protection for?
- How quickly can the vaccines be made available?
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