Sinovac/CoronaVac

Characteristics of COVID-19 Vaccines in Relation to Pregnancy and Lactation

Active ingredient

Inactivated whole virus

Delivery vehicle

Not needed

Method of administration

Deltoid IM injection

Recommended schedule

2 intramuscular injections, 2–4 weeks apart (WHO Strategic Advisory Group of Experts on Immunization). 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 SinoVac are given a booster shot, but of a different COVID-19 vaccine, such as Oxford/AstraZeneca: AZD1222.

Dosage per shot

Adult: 0.5 mL 3 μg per 0.5 mL

Ages

18 years and older (As of September 9, 2021)

Efficacy

Various efficacies, ranging from 50.4 to 94 percent have been cited, mostly in preprint reports that have not been peer reviewed. The peer reviewed Lancet paper cited in this description (Tanriover et al. 2021) reports an efficacy of 83.5 percent against PCR-confirmed symptomatic COVID-19 beyond 14 days after the second dose. As with all of the approved COVID-19 vaccines, the general finding efficacy is very high against the outcomes of severe COVID-19 disease and death. With this vaccine, efficacy against infection and mild disease may possibly be on the low side. Data are particularly lacking when it comes to efficacy against the Delta variant and other variants that are particularly common and problematic 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 Sinovac/CoronaVac 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 the Sinovac/CoronaVac 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.

Relation to Pregnancy and Lactation

Against endemic variants of SARS-CoV2, including the delta variant, while pregnancy is a risk factor for the development of severe COVID-19 in unvaccinated women and for preterm birth.

Adverse effects

Injection site : pain, erythema, swelling at injection site

Systemic : fatigue, headache, myalgia, chills, fever, nausea

There have been extremely rare, anecdotal reports of Bell palsy in association with the SinoVac/CoronaVac vaccine.

Pregnancy and Lactation Positions by Country for the Sinovac Vaccine (CoronaVac)

Sources

Lopez Bernal J, Andrews N, Gower C. Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. N Engl J Med. 2021 Jul 21. doi: 10.1056/NEJMoa2108891.

Tanriover MD, Doğanay HL, Akova M, et al.; CoronaVac Study Group. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213-222. doi: 10.1016/S0140-6736(21)01429-X. Epub 2021 Jul 8. PMID: 34246358; PMCID: PMC8266301.

World Health Organization (WHO) The Sinovac-CoronaVac COVID-19 vaccine. Accessed September 9, 2021

World Health Organization (WHO) Vaccine Tracker: SinoVac/CoronaVac. Accessed September 9, 2021