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SINOVAC Announces Positive Data on Booster Shots of CoronaVac®, Induces Strong Immune Response in Adult and Elderly Populations

BEIJING–()–SINOVAC Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced today the publication of two papers, which are available on Medrxiv. The publications detail findings from clinical studies on the immunogenicity, safety, and immune response of CoronaVac® in two- and three-dose schedules. The results indicate that a third booster dose of CoronaVac® induces a strong immune response in healthy adults with no serious adverse reactions related to the vaccine. This research provides important scientific data and supplement existing research to help policymakers develop strategies for vaccine rollout and timing of booster doses.

The first paper, titled Immunogenicity and safety of a third dose, and immune persistence of CoronaVac vaccine in healthy adults aged 18-59 years: interim results from a double-blind, randomized, placebo-controlled phase 2 clinical trial, includes published data on the immunogenicity and safety profile of a two-dose schedule, as well as interim results on immune persistence and the immunogenicity and safety of a third dose of CoronaVac® in healthy adults aged 18 to 59 years old.

The study is part of the placebo-controlled, double-blind phase II clinical trial in healthy adults aged 18 to 59 years old, conducted in China. Participants were randomly assigned (1:1:1:1) to one of four schedules to receive a third dose of vaccine, 28 or 6 months after two two-dose regiments, 14 or 28 days apart. The immunization schedule of the three-dose regimens for the four arms were: (1) days 0, 14, 42; (2) days 0, 14, 54; (3) days 0, 28, 56; and (4) days 0, 28, 268.

The results indicated that a two-dose schedule generates good immune memory. A third dose given 6 to 8 months after the second dose quickly induced a strong immune response, and the neutralizing antibody titers at day 28 after the third dose increased by three to five times higher than the levels recorded on day 28 after the second injection. In addition, the findings revealed evidence that show longer intervals between the second and third doses will result in higher antibody levels.

Seropositive rates in all dose groups were above 90.0% on day 28 after both the second and third doses. The severity of solicited local and systemic adverse reactions reported within 28 days after the third dose were grade 1 to grade 2 in all vaccination cohorts. No serious adverse reactions were considered to be related to vaccination, and a lower rate of adverse reaction was observed after the third dose compared to the two-dose schedule.

The second paper, titled A booster dose is immunogenic and will be needed for older adults who have completed two doses vaccination with CoronaVac: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, includes published data on the immunogenicity and safety profile of a third dose of CoronaVac® in healthy adults aged 60 and above, as well as research on the immune persistence of two priming doses.

The results showed that a third dose of the vaccine administered 8 months after the second dose can induce a significant increase of neutralizing antibodies at day 7 post-injection. In addition, a third dose was found to be well-tolerated in elderly patient populations with no vaccine-related serious adverse events reported.

The study is part of randomized, double-blind, placebo-controlled, phase 1/2 clinical trial conducted in China in healthy adults aged 60 and above, conducted in China. The study recruited 303 participants that who were assigned to groups and given a third dose of 3μg, 6μg or placebo eight months after the second dose. An additional arm of 1.5μg per dose was added to the study.

The results indicate that, in all 1.5μg, 3μg, and 6μg dose vaccine groups, the level of neutralizing antibodies increased significantly on day 7 after the third dose of vaccine. In the group of participants who received the 3μg vaccine, which is approved for emergency use, the geometric mean titer (GMT) of serum neutralizing antibodies increased to 305 on day 7 after the third dose of vaccine, which was approximately 7-fold as compared to the levels at day 28 after the second dose. The GMT levels continued to increase on days 14 and 28 after the third dose; however, there were no significant differences in the levels recorded days 14, 28 and 7 after the administration of a third dose. Furthermore, no significant differences in neutralizing antibody levels were observed among different age groups (60 to 64 years old, 65 to 69 years old, 70 years old and above).

The safety data showed that, within 28 days after the subjects received the third dose of vaccine, there was no significant difference in incidence of adverse reactions between the different arms vaccine and the placebo groups. Any reported adverse reactions were grade 1 or 2, the most common reaction being injection-site pain. No serious vaccine-related adverse reactions were observed.

Reference

[1] Immunogenicity and safety of a third dose, and immune persistence of CoronaVac vaccine in healthy adults aged 18-59 years: interim results from a double-blind, randomized, placebo-controlled phase 2 clinical trial. doi: https://doi.org/10.1101/2021.07.23.21261026

[2] A booster dose is immunogenic and will be needed for older adults who have completed two doses vaccination with CoronaVac: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. doi: https://doi.org/10.1101/2021.08.03.21261544

About SINOVAC

SINOVAC Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent pneumococcal polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella, mumps and Poliomyelitis. SINOVAC’s COVID-19 vaccine, CoronaVac®, has been granted emergency use approval or conditional marketing authorization by over 50 countries or regions worldwide. Healive®, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by SINOVAC against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, SINOVAC was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. In 2021, SINOVAC’s Sabin-strain inactivated polio vaccine has approved for registration. The Company is developing several new products including combined vaccines. SINOVAC primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is seeking market authorization of its products in over 30 countries outside of China. For more information, please see the Company’s website at www.sinovac.com.

Safe Harbor Statement

This press release may include certain statements that are not descriptions of historical facts, but are forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation it filed or filed against it by others. Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price as a result of the trigger of the rights plan.

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