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The Bharat Biotech COVID-19 Vaccine in Pregnancy

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

COVAXIN Vaccine (BBV152) for COVID-19

Covaxin is a vaccine created to protect against infection by SARS-CoV-2 (the virus that causes COVID-19) and is produced by the Bharat Biotech company in India.

As of February 2022, Covaxin has been approved for emergency use by the World Health Organization (WHO) and is being administered in a growing number of countries, including Bahrain, Botswana, Guyana, India, Iran, Mauritius, Mexico, Nepal, Paraguay, Philippines, Trinidad and Tobago, Viet Nam, and Zimbabwe.

How the Covaxin Vaccine Works

Covaxin, or BBV152, is what scientists call a whole virion inactivated vaccine. Whole virion inactivated vaccines are one of the oldest strategies for producing vaccines.

Whole virion inactivated vaccines are produced by taking actual particles from the virus causing the disease (of SARS-CoV2 in this case) and treating them in ways that ‘kills’ them.

Since viruses are not acutely living organisms, “killing” them, for the purpose of creating a vaccine, really means the particles are being inactivated.

Inactivating these particles means that the virus particles, although appearing to the immune system exactly like a working SARS-CoV2 virus, are incapable of infecting cells and reproducing within the host.

In the case of Covaxin, the inactive particles consist of the specific variant of SARS-CoV2 identified at the beginning of the COVID-19 pandemic.

These inactivated virus particles contain spike glycoprotein, the protein that other COVID-19 vac-cines cause your cells to make, as well as other proteins. They also contain everything else that is found in an active SARS-CoV2 virus. Consequently, there are many different regions on the inactivated virus particles that the immune system can use for “target practice” to help the vaccinated person build immunity against SARS-CoV2.

Who Is Able To Receive Covaxin?

Covaxin can be administered to individuals 18 years of age and older.

How the Covaxin Vaccine is Administered

The Covaxin vaccine is injected into the deltoid muscle of your shoulder over the course of two injections given 28 days apart.

In the case of some other COVID-19 vaccines, however, some countries have been spacing the initial two doses (the primary series) more than four weeks in certain group of people.

As of February 2022, for instance, the US Center for Disease Control and Prevention (CDC) is considering an option to increase the interval between the first two doses of mRNA COVID-19 vac-cines (Pfizer-BioNTech and Moderna) to less the occurrence of an already rare pair of adverse effects called myocarditis and pericarditis.

Affecting mostly young males, these phenomena seem to be related mostly to the mRNA vaccines, which do not include Covaxin.

During the first half of 2021, some information from studies suggested that a longer interval be-tween the two doses of vaccine might lead to better, longer lasting immunity. If this is true, it would apply to any approved COVID-19 vaccine, but the matter has not yet been resolved.

Additionally, many people in the United States and other countries have received third shots (“boosters”) of the approved vaccines. In places where Covaxin receives authorization, people who received two shots of a different COVID-19 vaccine (or one shot of the Janssen vaccine) will likely be able to receive Covaxin as their third shot. In other words, Covaxin will likely to be accepted within the mix and match framework of COVID-19 vaccines.

The dosage of each Covaxin shot is 0.5 mL.

Effectiveness and Safety of the Covaxin Vaccine

Clinical research conducted on those18 years and older suggests that two doses of Covaxin, spaced by an interval of 28 days has the efficacy of 77.8 percent against COVID-19 of any severity (SARS-CoV2 infection with any symptoms).

Covaxin’s efficacy decreased to 68 percent for people 60 years of age and higher. Meanwhile, in protecting against severe COVID-19, the vaccine was shown to be 93 percent effective in adults exposed to the virus at least 14 days after the second dose of the vaccine.

In protecting against SARS-CoV-2 infection without symptoms, Covaxin was shown to be 64 per-cent effective.

These numbers represent efficacy against the five different variants of the virus that comprised most of the infections throughout 2021. However, the numbers do not represent effectiveness against the Omicron variant that appeared in November 2021 and has since become the most com-mon variant worldwide.

A study posted in January 2022 as a preprint (not yet reviewed by other scientists) reports that se-rum (liquid containing antibodies from blood) from people who had received a shot of Covaxin as a booster (third dose in people vaccinated initially with other COVID-19 vaccines) was 90 percent effective in neutralizing the Omicron variant. If the study passes review by other scientists and is published, it will provide laboratory evidence that Covaxin can be expected to work well against the Omicron variant.

Pregnancy and Lactation Issues

The World Health Organization (WHO) recommends vaccination in pregnant women “when the benefits of vaccination to the pregnant woman outweigh the potential risks”. Currently, the benefits of COVID-19 vaccination far outweigh potential risks, both in pregnancy and lactation.

The only exceptions to this are in rare cases of people who previously have suffered allergic reactions to ingredients in the vaccine, such as polyethylene glycol.

Although data are not available specifically on pregnant women, as of November 2021, WHO re-ported that India had vaccinated 120,000 pregnant women with Covaxin.

Initial reports have revealed only the minor type of adverse effects on those women. While studies of the Covaxin vaccine in pregnancy are planned, experience with other inactivated vaccines suggests that the effectiveness and safety should be similar in pregnant women as in non-pregnant women of the same age range.

Adverse Effects Of Covaxin

Undesirable effects at the injection site are very common and include pain, redness, and swelling. Common effects felt throughout the body include tiredness, headache, chills, fever, nausea, and muscle aches.

Pregnancy and Lactation Positions by Country for the Bharat Biotech Vaccine (Covaxin)

WHO What You Need to Know

References

Ella R, Reddy S, Blackwelder W et al. COVAXIN Study Group. Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomized, double-blind, controlled, phase 3 trial. Lancet. 2021 Dec 11;398(10317):2173-2184. doi: 10.1016/S0140-6736(21)02000-6. Epub 2021 Nov 11. PMID: 34774196; PMCID: PMC8584828.

COVID-19 Vaccine Bharat Biotech: Covaxin. Accessed February 10, 2022

Edara VV, Patel M, Suthar MS. Covaxin (BBV152) Vaccine Neutralizes SARS-CoV-2 Delta and Omicron variants medrxiv.org preprint paper (not yet peer reviewed, posted January 28, 2022, accessed February 10, 2022

World Health Organization. The Bharat Biotech BBV152 COVAXIN vaccine against COVID-19: What you need to know. Accessed February 10, 2022

World Health Organization. WHO issues emergency use listing for eighth COVID-19 vaccine. Accessed February 10, 2022

World Health Organization. COVID-19 vaccines side effects and safety. Accessed February 10, 2022

David Warmflash
Dr. David Warmflash is a science communicator and physician with a research background in astrobiology and space medicine. He has completed research fellowships at NASA Johnson Space Center, the University of Pennsylvania, and Brandeis University. Since 2002, he has been collaborating with The Planetary Society on experiments helping us to understand the effects of deep space radiation on life forms, and since 2011 has worked nearly full time in medical writing and science journalism. His focus area includes the emergence of new biotechnologies and their impact on biomedicine, public health, and society.

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