The third COVID-wave led by the Omicron variant has started in India. Although the initial data indicates that this wave will be milder than the previous Delta one with less hospitalization, still a large section of the population might get affected. At this point, when the Government of India has approved “Prevention” vaccine doses for the healthcare workers, elderly, and the vulnerable population, it is important to find out the cross immunity generated by mixing of the available vaccines. It is also crucial that the safety profiles are well-established before administrating different vaccines as prevention or booster dose.

AIG Hospitals, one of India’s largest tertiary care centres, along with researchers from the Asian Healthcare Foundation conducted a pilot study to determine the safety profile of mixing COVISHEILD and COVAXIN along with checking the antibody response. A total of 330 healthy volunteers who were not vaccinated and had no history of COVID infection were selected and screened for SARS-CoV-2 antibodies for the study. Out of these 330, 44 (~13%) participants were found to be seronegative, i.e., they didn’t have COVID-related antibodies. “One of the incidental findings of the study is the seropositivity among our population. 87% participants who didn’t get vaccinated and never tested positive for COVID had the COVID-related antibodies. This means our population might have developed significant antibodies against the COVID because of the huge Delta wave that we endured,” said Dr. D Nageshwar Reddy, Chairman, AIG Hospitals.

The 44 participants were divided into two four groups.

Group 1: First Dose COVIDSHEILD + Second Dose of COVISHEILD

Group 2: First Dose of COVAXIN + Second Dose of COVAXIN

Group 1 and 2 were the homologous vaccine groups in which same vaccine have been given and relevant antibody titers were checked.

Group 3: First Dose of COVISHEILD + Second Dose of COVAXIN

Group 4: First Dose of COVAXIN + Second Dose of COVISHEILD

 Group 3 and 4 were the heterogenous vaccine groups in which different vaccines were given and antibody titers were checked.

All these 44 participants were followed for 60 days to see if there’re any adverse effects. The study conclusively showed that mixing of vaccines are absolutely safe as none of the participants developed any adverse effect.

The most important finding of the study was that the Spike-protein neutralizing antibodies found in the mixed vaccine groups were significantly higher than the same-vaccine groups. Dr. Reddy, who is also among the researchers, involved in the study said “Spike-protein neutralizing antibodies are the ones which kills the virus and reduces the overall infectivity. We found that when the first and second dose are of different vaccines, the Spike-protein antibody response is four times higher compared to two-dose of same vaccine.”

This is particularly important when considering the third booster dose. The concept of a booster is to elicit robust antibody response and help in killing the virus. Mixed doses can certainly boost these Spike-protein neutralizing antibodies and will enhance the vaccines’ effectiveness even against the Omicron variant,” Dr. Reddy further added.

The study results show that mixing of COVID Vaccines (COVISHEILD and COVAXIN) provide higher antibody response and is safe as well.

Furthermore, AIG Hospitals has shared the data from the study with the ICMR (Indian Council for Medial Research) to be considered as a reference study while deciding on the “Prevention” doses starting January 10th.

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Hyderabad, November 04,2021: Bharat Biotech, a global leader in vaccine development and innovation, today announced that COVAXIN®, India’s first indigenous Covid-19 vaccine, has been granted Emergency Use Listing by the World Health Organization (WHO). This vaccine is a whole virion-inactivated vaccine against SARS-CoV2, developed in partnership with ICMR and NIV, Pune.

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics, while adhering to stringent criteria of safety, efficacy and quality.

With validation fromthe WHO, countries can now expedite their regulatory approval processes to import and administer COVAXIN®. Furthermore, UNICEF, Pan-American Health Organization (PAHO), GAVI COVAX facility, will be able to procure COVAXIN® for distribution to countries worldwide. This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access.

Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said,“Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious COVAXIN®. As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification. The EUL authorisation for COVAXIN® will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency.”

The phase 3 trial data for COVAXIN® was available during June 2021. The World Health Organisation (WHO) Emergency Use Listing (EUL) process commenced on July 6, 2021, with rolling data submission. The Strategic Advisory Group of Experts on Immunization (SAGE) of WHO had reviewed COVAXIN® data on October 5 in a meeting and granted EUL for COVAXIN® today (November 3, 2021). COVAXIN® has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8ºC. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.

Mrs. Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “The WHO nod for COVAXIN® is a validation of the tremendous effort made by everyone at Bharat Biotech and our partners. It is also an opportunity for us to create meaningful impact at a global level. Such an impact can only be orchestrated when multiple stakeholders come together to work towards a common goal. COVAXIN®is a great example of a successful public-private partnership in developing a world-class COVID-19 vaccine.  We look forward to playing a larger role to help the efforts by both the developed and developing nations to control the pandemic.”

COVAXIN® has been evaluated through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies and others have been extensively published in more than 12peer-reviewed journals and available for review in the public domain.

Manufacturing capacity expansion was started during Q1 2021, as the first phase 3 efficacy readouts were available. Within a short period of ~9 months, the capacity was scaled up to 50-55 million doses per month, as of October 2021. Bharat Biotech has established COVAXIN® manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021. Technology transfer activities are also in progress to companies in India, the United States, and other countries.

More about COVAXIN^® – https://www.bharatbiotech.com/covaxin.html

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With the largest inoculation vaccine drive that started on Saturday, India has successfully administered the first jab of vaccine to lakhs of frontline workers. Two made-in-India vaccines, Covishield and Covaxin were administered to priority groups in the past two days. Thousands of people in Karnataka received their first shot while others are awaiting their turn.

India which had seen a severe virus outbreak has rolled out the vaccine at the earliest among the other Asian countries. The vaccine has come as a sigh of relief for people and could aid in ending the COVID trauma experienced by people over the last 10 months.

Let’s understand all about the COVID-19 vaccination drive in India:

• There are two made-in-India vaccines, Covishield, manufactured by Serum Institute and Covaxin, made by Bharat Biotech.
• Two doses will be injected within a gap of 28 days, the effectiveness will begin 14 days after the second dose.
• The vaccine has been introduced only after approval from the regulatory bodies. The authorities are making sure that the vaccines are kept at 2-8 degree Celsius during transit and storage.
• Possible side-effects include pain at the injection site, mild fever, fatigue, allergies, nausea, etc which can be relieved by simple medication.
• People with a previous history of Covid-19 infection, chronic diseases and comorbidities, immunodeficiency or HIV are considered safe to receive the vaccine.
• The vaccine will be given to 1 Crore private and public healthcare workers followed by 2 crore frontline administrative and municipal workers and people above the age of 50 years.
• Those who wish to register for the vaccine can do the same through CoWIN website using a government photo ID. Information on the allocated date and time will be sent to the given mobile number via an SMS

The recipients of the vaccine have been found to be safe without much side effects so far. While this vaccine administration is voluntary, it is recommended to take the vaccine for protection against COVID-19. Also, it is mandatory to wear mask and follow the COVID protocols like social distancing and washing or sanitising hands even after the vaccine has been administered.

India has the capability and experience in conducting massive vaccination drives in the past, the ongoing drive will also continue in the same manner with the support of the frontline workers and government officials. During these unprecedented times, the rollout of vaccination drive will certainly be a boon for the country in terms of effective health infrastructure and economic recovery.

Over 750 hospital staff at Columbia Asia Hospital Whitefield, Columbia Asia Referral Hospital Yeshwanthpur, Columbia Asia Hospital Hebbal and Columbia Asia Hospital Sarjapur Road received their first jab with pride and a sense of relief in the vaccination drive held in the past two days.

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