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The Sinopharm 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.

Active ingredient

Inactivated whole virus. The virus was cultivated (grown encouraged to replicate in large numbers) in a Vero cell line (from monkeys), using a viral sample isolated from a COVID-19 patient at Jinyintan Hospital, Wuhan, China.

Delivery vehicle

Not needed

Method of administration

Intramuscular injection into the deltoid (upper arm)

Recommended schedule

2 intramuscular injections, 3–4 weeks apart (WHO). If the interval goes beyond 4 weeks, the second shot should be given as soon as possible. As of September, 2021, policies in various countries are developing and evolving with respect to a third dose. In many cases, people who have received two doses of Sinopharm/CovV are given a booster shot, but of a different COVID-19 vaccine, such as Oxford/AstraZeneca: AZD1222.

Dosage per shot

Adult: 0.5 mL

Ages

18 years and older (As of September 9, 2021). The WHO approved the vaccine May 7, 2021.

Efficacy

Based on Phase 3 trials conducted as of Septermber 2021, follwoing two doses, spaced by 21 days, efficacy 14 or more days after the second shot is reported at 79 percent against symptomatic SARS-CoV-2 infection and also 79 percent against hospitalization (preventing the need to be hospitalized). Other numbers cited in reports are 72.8 percent and 78.1 percent against symptomatic infection. However, women have been underrepresented in the phase 3 trials completed by September 2021 and trials leave uncertain regarding efficacy against severe disease in pregnant women and in those with medical comorbidities and those above 60 years of age. Women were underrepresented in the trial. More data will come from additional trials. The WHO Strategic Advisory Group of Experts (SAGE).

As for efficacy against particular SARS-CoV2 variants, it is important to note that, as mentioned above, the vaccine was produced by cultivating a virus isolated from a Wuhan patient, which means a virus from very early in the COVID-19 pandemic. Creating an inactivated virus that is cultivated in cell culture is a long process, which means it would be a longer process to create this type of vaccine directed particularly against a new variant than it would take to create a new mRNA vaccine against that same variant. The is because mRNA vaccines (which include the Pfizer/BioNTech and Moderna COVID-19 vaccines) can be created a new by simply creating a new sequence for the mRNA, analagus to writing new software. That said, the Sinopharm vaccine may prove to have good efficacy against variants such as Delta and may not need to be improved, but there aren’t data yet available to make that determnination as of September 2021.

PREGNANCY & LACTATION

Currently, the benefits of COVID-19 vaccination far outweigh potential risks both in pregnancy and lactation, other than in rare cases of people who previously have suffered allergic reactions to ingredients in the vaccine. The Sinopharm/CorV vaccine consists of an inactivated virus with an adjuvant. Based on experience other vaccines of this type, such as tetanus vaccines, along with the lack of a plausible mechanism by which an inactivated viral vaccine might cause harm, there is no for avoiding this particular vaccine during pregnancy. Consequently, the World Health Organization (WHO) recommends any WHO- approved COVID-19 vaccine in pregnant women “when the benefits of vaccination to the pregnant woman outweigh the potential risks”. To help pregnant women make this assessment, they should be provided with information about the risks of COVID-19 in pregnancy; the likely benefits of vaccination in the local epidemiological context; and the current limitations of safety data in pregnant women. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or considering terminating pregnancy because of vaccination.

Adverse effects

Injection site : pain, erythema (redness), swelling at injection site

Systemic : fatigue, headache, myalgia (muscle pain), chills, fever, nausea Serious adverse effects have been very rare

Pregnancy and Lactation Positions by Country for the Sinopharm Vaccine (BIBP-CorV)

WHO What You Need to Know

Sources

Ma ML, Shi DW, Li Y, Hong W, et al.. Systematic profiling of SARS-CoV-2-specific IgG responses elicited by an inactivated virus vaccine identifies peptides and proteins for predicting vaccination efficacy. Cell Discov. 2021 Aug 17;7(1):67. doi: 10.1038/s41421-021-00309-7. PMID: 34400612; PMCID: PMC8367966.

Precision Vaccinations. Sinopharm COVID-19 Vaccine (BBIBP-CorV). Accessed September 23, 2021

World Health Organization (WHO) Sinopharm (Beijing): BBIBP-CorV (Vero Cells). Accessed September 9, 2021

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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