Bharat Biotech COVID-19 vaccine

Extended version of the vaccine

Bharat Biotech COVID-19 vaccine

Authorization

World Health Organization Emergency Use Listing Procedure
Not authorized.
Expression of interest submitted [last checked at WHO EUL official website on 30 September 2021].

European Commission (based upon the recommendation of the European Medicines Agency [EMA])
Not authorized.

Central Drugs Standard Control Organization (CDSCO, India)
Authorized [Ministry of Health and Family Welfare. Government of India, 2021 ].
3 January 2021
Conditional marketing authorization in individuals 18 years of age and older.

Regulatory Authorities of Regional Reference in the Americas

National Administration of Drugs, Foods and Medical Devices (ANMAT, Argentina)
Not authorized.

Brazilian Health Regulatory Agency (ANVISA, Brazil)
Not authorized.

Health Canada
Not authorized.

Public Health Institute (ISP, Chile)
Not authorized.

National Institute of Food and Drug Monitoring (INVIMA, Colombia)
Not authorized.

Center for the State Control of Drug Quality (CECMED, Cuba)
Not authorized.

U.S. Food and Drug Administration (FDA)
Not authorized.

Federal Commission for the Protection against Sanitary Risk (COFEPRIS, Mexico)
Authorized for emergency use: 06 April 2021 [COFREPRIS, 2021 ]

Authorization in other jurisdictions in the Americas
Guatemala
Guyana
Paraguay
Venezuela

Authorization in other jurisdictions
Iran
Mauritius
Nepal
Philippines
Zimbabwe

Manufacturing

Manufacturer
Bharat Biotech, India: Bharat Biotech COVID-19 vaccine from India was developed in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV). The indigenous inactivated vaccine is developed and manufactured by Bharat Biotech.

Other manufacturers
Indian Immunologicals Ltd (IIL), located in India, will start the production of the vaccine by July/August 2021, using the same technology of Bharat Biotech
Ocugen Inc, USA, partnered with Bharat Biotech to co-develop the COVID-19 vaccine candidate for the U.S. market.
Precisa Medicamentos pharmaceutical, Brazil, signed an agreement with Bharat Biotech for the supply of its COVID-19 vaccine and for it to be manufactured locally in Brazil.
Haffkine Biopharma Corporation, India, received permission from the Union government to manufacture the vaccine.

General characteristics

The virus strain used to produce Bharat Biotech COVID-19 vaccine is the NIV-2020-770. isolated and sequenced from a COVID-19 patient. It contains the Asp614Gly mutation, which was almost universally prevalent by the end of April 2020. This mutation is found in the S1 domain of the spike protein and does not determine any difference in the antigenic potential of the epitope [Yogendra Shrestha, 2021 ].
The agent used for inactivaction is β-Propiolactone, an organic compound utilized to inactivate a wide variety of viruses in vaccine production [Gao Q, 2020 ].

The adjuvant is Algel-IMDG, an imidazoquinoline molecule absorbed to alum, a toll-like receptor 7/8 agonist that traffics vaccine antigen directly to draining lymph nodes without diffusing into the systemic circulation [Ella R, 2021 ].


Dosage form and ingredients
The pharmaceutical form is a suspension for intramuscular injection that is provided as a monodose vial of 0.5 ml or, as a multidose vial of 10 doses (5 mL) and 20 doses (10 mL).
The vaccine contains the following ingredients:
Active ingredient
6µg of whole-virion inactivated SARS-CoV-2 antigen (Strain: NIV-2020-770).
Excipients
250 µg of aluminum hydroxide gel.
15 µg of TLR 7/8 (imidazoquinolinone)
2.5 mg of 2-phenoxyethanol.
0.5 mL of phosphate buffer saline.

Risk considerations

Studies performed in mouse models on SARS-CoV and MERS-CoV showed that animals exposed to whole inactivated vaccines exhibited an immunopathologic-type lung disease.
[Tseng CT, 2012 ].
Purified inactivated viruses have been traditionally used for vaccine development and such vaccines have been found to be safe and effective for the prevention of diseases caused by viruses like influenza and poliovirus [Gao Q, 2020 ].
Studies performed in mouse models on SARS-CoV and MERS-CoV showed that animals exposed to whole inactivated vaccines exhibited an immunopathologic-type lung disease. [Tseng CT, 2012 ]. This condition would be probably caused by a response from type 2 (Th2) helper T cells. Although the cellular response can be elicited by many vaccines, protection against subsequent coronavirus infections is largely mediated for humoral immunity. The 'cytokine storm' induced by excess T cells has been shown to accentuate the pathogenesis of COVID-19 [Qiang Gao, 2020 ].

Dosification and schedule

Dose-finding studies
The BBIL/BBV152-A/2020 trial assessed 380 healthy participants aged 12 to 65 years that received two vaccination schedules, 3 µg with Algel-IMDG or 6 µg with Algel-IMDG. Vaccines were administered intramuscularly at a volume of 0.5 mL per dose in a two-dose regimen on day 0 and day 28. Findings showed that seroconversion rates were 98.4% (95% CI 95.3 to 99.7) in the 3 µg with Algel-IMDG group and 96.6% (95% CI 92.8 to- 98.8) in the 6 µg with Algel-IMDG group, at day 56. Both doses of the vaccine-induced significant neutralizing antibody responses to live SARS-CoV-2 [Ella R, 2021 ].

There is no evidence yet about the effects of the coadministration of Bharat Biotech COVID-19 vaccine with other vaccines included in routine vaccination programs

Indications and contraindications

Indications
Bharat Biotech COVID-19 vaccine is indicated in adult individuals 18 years of age and older [Central Drugs Standard Control Organization of the Government of India, 2021 ].

Contrandications
The vaccine is contraindicated in individuals with a known history of a severe allergic reaction to any component of the vaccine (see the list of ingredients under 'General characteristics' in the extended version).
The second dose of the vaccine should NOT BE GIVEN to those who have experienced anaphylaxis to the first dose of Bharat Biotech COVID-19 vaccine.
Bharat Biotech COVID-19 vaccine is contraindicated in pregnant and lactating females [Central Drugs Standard Control Organization of the Government of India, 2021 ].
Bharat Biotech COVID-19 vaccine is contraindicated in individuals below 18 years of age [Central Drugs Standard Control Organization of the Government of India, 2021 ].

Precautions
Severe allergic reaction (e.g., anaphylaxis) to a previous dose of any vaccine (not including Bharat Biotech COVID-19 vaccine).
Severe allergic reaction (e.g., anaphylaxis) to an injectable medication
Vaccination should be postponed in individuals suffering from acute severe febrile illness, or acute infection.
As with other intramuscular injections, the vaccine should be given with caution in individuals with bleeding disorders or other conditions that increase the risk of bleeding, such as anticoagulant therapy, thrombocytopenia and hemophilia [Ministerio de Salud Pública y Bienestar Social, 2021 ].
Bharat Biotech COVID-19 vaccine may interact with chloroquine and corticosteroids impairing the immune antibody response [Central Drugs Standard Control Organization of the Government of India, 2021 ].
The interaction of concomitant administration of Bharat Biotech COVID-19 vaccine with other vaccines has not been studied.
There should be a minimum interval of 14 days between the administration of this vaccine with any other vaccine in the immunization schedule until data on co-administration with other vaccines are available.
Vaccination may be offered regardless of a person‘s history of symptomatic or asymptomatic SARS-CoV-2 infection.
Although there are currently no medical contraindications to vaccinate a person with COVID-19, it is recommended to defer all vaccinations until complete recovery [PAHO, 2020 ].
Although there are currently no contraindications to vaccinate a person who has had contact with a COVID-19 case, it is recommended to defer vaccination until the quarantine has been completed (14 days after the last exposure) [PAHO, 2020 ].

Close observation for at least 30 minutes is recommended following vaccination.

Storage and logistics

Storage
Bharat Biotech COVID-19 vaccine is provided as a suspension stored at 5°C/41°F (between 2°C to 8°C [35° to 46°F]).
Unopened vaccine vials can be stored refrigerated between 2°C to 8°C (35°F to 46°F) for up to 6 month [Ministerio de Salud Pública y Bienestar Social, 2021 ].
Vials can stay at room temperature for up to 6 hours once vials are open [Ministerio de Salud Pública y Bienestar Social, 2021 ].
Protect the vials from light.
Do not freeze.

Logistic at the time of administration
Inspect the vial before administration.
The vial should be discarded if particles or differences are observed in the described appearance of the vaccine.
Shake the vial gently.
Once the multidose vial of the vaccine is opened, it can be stored between 2°C and 8°C (36 ° F to 46 ° F) for up to 6 hours or until the last dose is used, whichever occurs first. [Ministerio de Salud Pública y Bienestar Social, 2021 ]
Storage after first puncture
After the first puncture of the vial, preferably use immediately.
Record the date and time the vial should be discarded.
To improve traceability, the name and batch number of the administered product should be clearly recorded

Administration
1.Using aseptic technique, clean the vial stopper with a single-use antiseptic swab.
2. Use a 3 ml reuse prevention syringe (RUP) or a 5 ml RUP syringe, and a 21G or narrower needle.
3. Gently invert the vial to mix, and withdraw the 0.5 ml dose. If the amount of vaccine remaining in the vial cannot provide a full 0.5 ml dose, discard the vial and the remaining volume.
4. Administer the vaccine intramuscularly, preferably into the deltoid muscle. Do not administer the vaccine intravascularly, subcutaneously, or intradermally.

Disposal
Due to the high risk that discarded vials of COVID-19 vaccines may be recovered, it is essential that they are guaranteed to be safely disposed of at the site of use; or study the possibility of applying reverse logistics, if the safe treatment and disposal of vaccine residues cannot be guaranteed, so that they are transferred to the place established for that purpose. Otherwise, consider the possibility that the discarded vaccine vials are shredded, if there is a safe way to do so [WHO, 2021 ].

Clinical studies - general characteristics

Randomized trials
BBIL/BBV152-A/2020 was a phase 1/2, dose-escalation, randomized trial (registered with the number NCT04471519 [Bharat Biotech International Limited, 2020 ]), sponsored by Bharat Biotech International Limited that was conducted in India. In the phase 1 trial, the aim was to evaluate the safety, reactogenicity, tolerability, and immunogenicity the vaccine. It was first registered in July 2020 and enrolled 375 participants of 18 to 55 years of age that were randomized in a 4:1 ratio to receive either one of three vaccine formulations or a control vaccine. Results were published in a scientific journal on January 2021 [Ella R, 2021 ].
The phase 2 of the trial [Ella R, 2021 ] randomized 380 participants of 12 to 65 years of age in a 1:1 ratio to receive one of two vaccine schedules. The interim results of the trial were published in a scientific journal on March, 2021 [Ella R, 2021 ].

Ongoing randomized trials
BBIL/BBV152-C/2020 is an ongoing phase 3 trial (registered with the number NCT04641481 [Bharat Biotech International Limited, 2020 ]) sponsored by Bharat Biotech that is being conducted in India. It was first registered on November 16, 2020 and plans to enroll 25800 adults from 18 years of age and over, that will receive the vaccine or placebo, in a 1:1 ratio. It is expected to run until December, 2022. Preliminary results were announced through press release in March 2021 [Bharat Biotech, 2021 ].
Other studies providing efficacy or safety data
The following non-comparative studies have reported efficacy or safety data: Srivastava et al [Srivastava RK, 2021 ]; Singh et al [AWADHESH KUMAR SINGH, 2021 ]; Parai et al [Parai D, 2021 ]; Tyagi et al [Tyagi K, 2021 ]; Arora et al [Arora P, 2021 ]; Khawaja et al [Khawaja T, 2021 ].

Methods used to assess efficacy and effectiveness

There are no phase 3 randomized trials that have yet reported outcome data.

Methods used to assess safety

There are no phase 3 randomized trials that have yet reported outcome data.

Efficacy and effectiveness of the vaccine

Efficacy of the vaccine in preclinical studies

Immunogenicity of the vaccine has been evaluated in mice, rats and rabbits [Ganneru B, 2021 ], Syrian hamsters [Mohandas S, 2021 ] and non-human primates [Yadav PD, 2021 ].
Ganneru et al assessed immunogenicity of the vaccine at two antigen concentrations (3µg and 6µg), with two different adjuvants, in mice, rats and rabbits. All formulations generated significantly high antigen-binding and neutralizing antibody titers, at both concentrations, in all three species. The formulation containing TLR7/8 agonist adjuvant-induced Th1 biased antibody responses with elevated IgG2a/IgG1 ratio and increased levels of SARS-CoV-2 specific IFN-γ+ CD4+ T lymphocyte response [Ganneru B, 2021 ].

Mohandas et al assessed immunogenicity of different vaccination regimes in Syrian hamsters (BBV152A, BBV152B, and BBV152C). All the regimes induced significant titers of SARS-CoV-2-specific IgG and neutralizing antibodies. Post-SARS-CoV-2 infection, vaccinated hamsters did not show any histopathological changes in the lungs. Of the three candidates, BBV152A showed the better response.

Yadav et al assessed immunogenicity of three different vaccine schedules, at day 0 and 14, in 20 rhesus macaques. A protective response was observed with increasing SARS-CoV-2 specific IgG and neutralizing antibody titers from 3rd week post-immunization. No evidence of pneumonia was observed by histopathological examination in the vaccinated groups [Yadav PD, 2021 ].

Efficacy of the vaccine in clinical trials

Main immunogenicity outcomes

BBIL/BBV152-A/2020 trial evaluated the immunogenicity of a two-dose schedule with three different formulations of the vaccine in participants 12 to 65 years old. The vaccine induced high neutralising antibody responses that remained at 3 months after the second vaccination. The 6 µg with Algel-IMDG formulation was selected for the phase 3 efficacy trial [Ella R, 2021 ].

The phase 3 BBIL/BBV152-C/2020 trial evaluated the consistency of immune responses from three consecutive manufacturing batches. The results showed that the neutralizing antibodies of the mean antibody titers in the groups that received lots 1, 2, 3 or placebo were 130.3 (95% CI: 105.8-160.4), 121.2 (97.6-150.5), 125.4 (101.3-155.1), and 13.7 (10.7-17.4) respectively on day 56. Antibody titers were higher (194, 3 [95% CI 134.4-280.9, n = 48] in vaccinated participants who were seropositive for SARS-CoV-2 at baseline [40b42c59d7d5e26930510ba5afíritu78a6a82e36f].

Main efficacy outcomes of Bharat Biotech COVID-19 vaccine

Key messages

There is no evidence available at this moment to assess the efficacy of Bharat Biotech COVID-19 vaccine.

Contracting COVID-19 (measured at least 14 days after the second injection)

The relative risk of Bharat Biotech COVID-19 vaccine in the group that received Bharat Biotech COVID-19 vaccine, versus the group that received control vaccine was 0.23 (95% CI 0.15 to 0.35). This means Bharat Biotech COVID-19 vaccine reduced the risk of contracting COVID-19 by 77%, compared with control vaccine.

Figure - Forest plot of risk ratio meta-analysis. Outcome: contracting COVID-19. Comparison: control vaccine versus Bharat Biotech COVID-19 vaccine

In the trials identified in this review, 24 people not receiving Bharat Biotech COVID-19 vaccine out of 8471 presented this outcome ( per ) versus out of would avoid contracting COVID-19 in the group that did receive it ( per ). In other words, people per did not develop the outcome because of the vaccine. This is the same as saying that the intervention led to an absolute risk of %, or that the intervention the risk of by percentage points. Another way of presenting the same information about the absolute effects is the number needed to treat for an additional beneficial/harmful outcome (NNTB/H), the number of participants who need to receive the intervention for one of them to experience the outcome. In this case, the is . Which means that 59 people need to receive the vaccine for one of them to not contract COVID-19.

Efficacy and effectiveness of the vaccine on subgroups

Sex

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.
The differential efficacy of the vaccine in sex groups was not reported in the phase 1/2 trial BBIL/BBV152-A/2020 [Ella R, 2021 ].

Age

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, the percentage of participants by age was: 12-17 years: 3.7%; 18-54 years: 92%; 55-65: 4.3%. Seroconversion rates across the three age groups were similar [Ella R, 2021 ].

Children and adolescents

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, the percentage of participants 12 to 17 years of age was 3.7% (14 out of 380). Seroconversion rate in this age group was similar. Children <12 years were excluded [Ella R, 2021 ].

Pregnancy

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, pregnant females were excluded, so no data are available for this subgroup [Ella R, 2021 ].
Breast-feeding

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, breast-feeding females were excluded, so no data are available for this subgroup [Ella R, 2021 ].

Immunocompromised persons

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, immunocompromised patients were excluded, so no data are available for this subgroup [Ella R, 2021 ].

Other data from vaccine efficacy and effectiveness

Duration of protection

Randomized trials
The exact duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.

Comparative studies
None available.

Non-comparative studies
None available

Limitations of vaccine effectiveness

Individuals may not be fully protected until 14 days after their second dose. As with all vaccines, vaccination with Bharat Biotech COVID-19 vaccine may not protect all vaccine recipients.

SARS-CoV-2 variants

Randomized trials
None available.

Other studies
No significant reduction in neutralization of any SARS-CoV-2 variant of concern by sera of recipients of Bharat Biotech COVID-19 vaccine has been reported:
Sapkal et al evaluated the reduction in neutralization against variant alpha (also known as B.1.1.7, first documented in the United Kingdom) by sera from 38 recipients of Bharat Biotech COVID-19 vaccine. The study concluded that sera from the vaccine recipients did neutralize this variant [Sapkal GN, 2021 ].

Yadav et al evaluated the reduction in neutralization against variant delta (also known as B.1.617.2, first documented in India) by sera from 28 recipients of Bharat Biotech COVID-19 vaccine. The study concluded that sera from the vaccine recipients did neutralize this variant [Yadav PD, 2021 ].

Safety of the vaccine

Safety of the vaccine in preclinical studies

The safety of the vaccine has been evaluated in mice, rats and rabbits [Ganneru B, 2021 ]. Other preclinical studies did not assess safety outcomes [Mohandas S, 2021 ],[Yadav PD, 2021 ].
Ganneru et al assessed preclinical safety of either adjuvant-alone (Algel-IMDG) or three formulations of the vaccine in mice, rats and rabbits. The studies did not indicate any undesirable pathological changes and systemic toxicity, except local reactogenicity at the site of injection. Mutagenicity assay performed with Algel-IMDG at various concentrations revealed the adjuvant-alone or in combination with the adjuvanted vaccine formulation was non-mutagenic [Ganneru B, 2021 ].

Safety of the vaccine in clinical trials

There are no phase 3 randomized trials that have yet reported outcome data.

Any adverse event

There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, solicited local adverse were reported in 8 of 190 (4.2%) and 7 of 190 (3.7%) in the 3 and 6 µg groups, respectively. Solicited systemic adverse reactions after dose 2 were reported in 12 of 190 (6.3%) and 11 of 190 (5.8%) in the 3 and 6 µg groups, respectively [Ella R, 2021 ].

Non-serious adverse events

There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, non-serious adverse events related to immunization were not reported [Ella R, 2021 ].


Serious adverse events

There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, serious adverse events were not observed [Ella R, 2021 ].

Safety of the vaccine in subgroups

Sex

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

The differential safety of the vaccine in sex groups was not reported in the phase 1/2 trial BBIL/BBV152-A/2020 [Ella R, 2021 ].

Age

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

Adults older than 65 years were not included in the phase 1/2 trial. Safety in the different age groups included was not reported [Ella R, 2021 ].

Children and adolescents

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, the percentage of participants 12 to 17 years of age was 3.7% (14 out of 380). Differential safety in this age group was not reported. Children <12 years were excluded [Ella R, 2021 ].

Pregnancy

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, pregnant females were excluded, so no data are available for this subgroup [Ella R, 2021 ].

Breast-feeding

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, breast-feeding females were excluded, so no data are available for this subgroup [Ella R, 2021 ].

Immunocompromised persons

Randomized trials
There are no phase 3 randomized trials that have yet reported outcome data.

In the phase 1/2 trial BBIL/BBV152-A/2020, immunocompromised patients were excluded, so no data are available for this subgroup [Ella R, 2021 ].

Safety of the vaccine post-authorization

Post-authorization studies

Comparative studies
None available

Non-comparative studies
Srivastava et al was an observational study based on data from an electronic COVID-19 vaccination tracker conducted in India until February 2021 [Srivastava RK, 2021 ]. The study evaluated 1322 health workers that received the vaccine. The authors concluded the vaccine was only associated to minimal and minor side effects.

Singh et al is a nationwide cross-sectional study that is being conducted in India [AWADHESH KUMAR SINGH, 2021 ]. The study has evaluated 552 health workers that received the vaccine between 21 days after the first dose to 6 months after the second dose. Preliminary results showed an incidence of adverse events of 31.2% after the first dose.

Case reports and case series
None available.

Spontaneous report data

Disclaimer: Reporting suspected adverse reactions after authorization of the medicinal product is important because it allows continuous monitoring of the benefit/risk balance of the vaccines. However, they do not indicate a causal association between the vaccine and the observed effects. Furthermore, this information should not be used to estimate the frequency of adverse events in people receiving the vaccine or to make comparisons between different vaccines. The information emerging about possible adverse effects needs to be carefully evaluated in order to first establish if the adverse effect might have been caused by the vaccine.

Ninguno disponible.

Monitoring

− interchangeability studies within and across COVID-19 vaccine platforms.

References

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