Race for COVID-19 vaccine: Covaxin and ZyCoV-D begin human trials in India, Moderna publishes preliminary data from phase 1
While Covaxin is an inactivated whole-virion vaccine, ZyCoV-D is a DNA-plasmid based vaccine.
On 14 July, Balram Bhargava, the Director-General of the Indian Council of Medical Research (ICMR), announced in a press release that the human trials of a potential COVID-19 vaccine have started in the country.
Late last month, two Indian vaccine candidates — Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCoV-D — had received the approval from the Drug Controller General of India (DCGI) to begin the clinical trial phase (for phase I/II trials) after they were found to be safe in toxicity trials in rats, mice and rabbits.
While Covaxin is an inactivated whole-virion vaccine, ZyCoV-D is a DNA-plasmid based vaccine. As per Bhargava, the candidate vaccines will be tested on over 1,000 volunteers each at various sites in the country. Meanwhile, preclinical trials for these two and well as other vaccines are being done at National Institute of Virology (NIV), Pune to fast track the process of vaccine production.
In other related news, the preliminary reports from the Moderna vaccine candidates were published in the New England Journal of Medicine (NEJM) yesterday.
The two clinical trials: Bharat Biotech and Cadila
According to the latest update of the COVID-19 vaccine landscape from the World Health Organisation, Bharat Biotech has started taking in volunteers for their phase I/II clinical trial while Cadila is not yet recruiting. Both the companies have registered on the Clinical trial registry of India this month. Here are some of the details of the vaccine and the trials:
Bharat Biotech trials and vaccine: This vaccine is an intramuscular injection containing about 0.5 mL of three formulations of the inactivated SARS-CoV-2 virus: BBV152A, BBV152B and BBV152C.
The vaccine will be given in two doses - day 0 and day 14 - to healthy people within the age group of 12 and 65 years for the phase 2 trials and between 18 and 55 years for the phase 1 trials.
Out of the 1,125 volunteers in the study, about 375 will be enrolled in the phase 1 study and 750 in phase 2, with a 4:1 ratio between tests (ones who are given the vaccine) and controls (ones who are given the placebo). The placebo group will get a Japanese encephalitis vaccine.
Phase 1 part of the trial will look for possible side effects of the vaccine and the phase 2 part will look for the immunogenicity (ability to generate antibodies).
Zydus Cadila trials and vaccine: This vaccine is an intradermal injection which will have a DNA plasmid-based vaccine that will produce the membrane protein of the SARS-CoV-2 virus that helps it gain entry into the host cell. Three doses of the vaccine will be given on day 0, 28 and 56, while the control group will get a single dose of the placebo on day 0. Healthy individuals between 18 and 55 years will be included in phase I trials and anybody over 12 years of age would be enrolled for phase 2 trials. A total of 1,048 individuals would be recruited for both trials.
Both the vaccines have an estimated completion time of about one year.
The American Biotech company Moderna Inc. is developing an RNA-based vaccine that encodes for the spike protein of the COVID-19 causing virus. Earlier the firm had only released incomplete results which had raised major concerns about the vaccine.
The vaccine was tested on 45 individuals in three intramuscular doses - 25 µg (microgram), 100 µg and 250 µg. All the individuals were to be given two doses of the vaccine: one on day 1 and another on day 29. Here are some of the findings of the study:
- All the volunteers showed antibodies after the first dose of the vaccine. Those given higher doses showed a stronger immune response.
- After the second dose, the antibody levels increased in all volunteers.
- 100% of the volunteers in the 100 µg group showed neutralising antibodies and the level of these antibodies was more than what is seen in convalescent (recovering) patients.
- More than half of the participants reported fatigue, pain at the injection site, muscle pain, headache and chills after the injection. However, all these side effects were temporary.
- More than two participants in the 250 µg dose had reported severe adverse reactions - high-grade fever(103.2 degrees Fahrenheit).
- One person in the 25 µg group was suspected of having COVID-19 after the first injection (although not due to the injection) but he tested negative.
- One participant in the 25 µg group developed adverse urticaria (hives) on legs after the first injection.
The vaccine will enter phase 3 trials on 27 July
Here is a list of vaccines (other than the ones already mentioned) as per the WHO’s COVID-19 vaccine landscape in various stages of clinical trials:
- ChAdOx1-S by Oxford University and AstraZeneca has already entered phase 3 trials.
- An inactivated vaccine by Sinovac is in phase 3 trials.
- A non-replicating viral vector vaccine by CanSino Biological Inc and Beijing Institute of biotechnology is in phase I/II trials.
- A DNA based vaccine by Inovio Pharmaceuticals and International Vaccine Institute is in phase I/II trials.
- A DNA based vaccine by Osaka University, AnGes and Takara Bio is in phase I/II trials.
- An RNA based vaccine by BioNTech, FosunPharma and Pfizer is in phase I/II trials.
- A protein subunit vaccine by Novavax is in phase I/II trials.
- An inactivated vaccine by Beijing Institute of Biological Products and Sinopharm is in phase I/II trials.
For more information, read our article on How are vaccines made.
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