NEW DELHI: China’s Sinopharm is the first Chinese vaccine to be approved by the WHO.
The World Health Organization on Tuesday approved the Sinovac Covid-19 vaccine for emergency use — the second Chinese jab to receive the WHO’s green light.
The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell).
Its easy storage requirements make it highly suitable for low-resource settings.
It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.
Here is all you need to know about the Sinopharm vaccine:- Who is manufacturing the the Sinopharm vaccine?The Sinopharm vaccine is being manufactured by China National Pharmaceutical Group Co., Ltd.
China National Pharmaceutical Group Co., Ltd.
(Sinopharm) is a state-owned healthcare group with 128,000 employees and a full chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business and financial services.
Is it a single dose vaccine?No.
Sinopharm vaccine is to be given in two doses of 0.5 ml intramuscularly.
What’s the recommended dosage?WHO’s Strategic Advisory Group of Experts (SAGE) recommends the use of BIBP vaccine as 2 doses (0.5 ml) given intramuscularly.
WHO recommends an interval of 3–4 weeks between the first and second dose.
If administration of the second dose is delayed beyond 4 weeks, it should be given at the earliest possible opportunity.
It is recommended that all vaccinated individuals receive two doses.
Should pregnant women take Sinopharm vaccine?The available data on the vaccine in pregnant women are insufficient to assess either vaccine efficacy or vaccine-associated risks in pregnancy.
However, this vaccine is an inactivated vaccine with an adjuvant that is routinely used in many other vaccines with a documented good safety profile, including in pregnant women.
The effectiveness of the Covid-19 vaccine BIBP in pregnant women is therefore expected to be comparable to that observed in non-pregnant women of similar age.
Who is the vaccine not recommended for?Individuals with a history of anaphylaxis to any component of the vaccine should not take it.
Anyone with a body temperature over 38.5ºC should postpone vaccination until they no longer have a fever.
What is the efficacy of the Sinopharm vaccine?A large multi-country Phase 3 trial has shown that 2 doses, administered at an interval of 21 days, have an efficacy of 79% against symptomatic SARS-CoV-2 infection 14 or more days after the second dose.
Vaccine efficacy against hospitalization was 79%.
The trial was not designed and powered to demonstrate efficacy against severe disease in persons with comorbidities, in pregnancy, or in persons aged 60 years and above.
Women were underrepresented in the trial.
The median duration of follow-up available at the time of evidence review was 112 days.
Two other efficacy trials are under way but data are not yet available.
Howver, there have been concerns about the efficacy of the Sinopharm vaccine due to limited published clinical data being available.
The news of Covid cases rising in Seychelles, where Sinopharm shots were issued to 57% of those who were fully inoculated, has also raised some questions about its efficacy Is the vaccine safe?WHO has thoroughly assessed the data on quality, safety and efficacy of the vaccine and has recommended its use for people aged 18 and above.
Safety data are limited for persons above 60 years of age (due to the small number of participants in clinical trials).
Which countries have approved the vaccine so far? Vietnam today approved China’s Sinopharm vaccine for use against Covid-19, state media reported, making it the third shot to be endorsed in the Southeast Asian country.
Other countries that have approved the vaccine include Pakistan, Bahrain, Turkey, UAE, Peru, Morroco, Jordan, Egypt and Hungary.