Geneva: While there has been global concern and doubts about Chinese covid-19 vaccines, China’s Sinopharm COVID-19 vaccines, very much used globally, have been considered both safe and efficacious, according to Mariangela Simao, World Health Organization (WHO) assistant director general for access to health products.
“We still have data proving that they are efficacious against severe disease,” she said in a press conference.
“Sinopharm has been very much used globally. I think 62 million doses have already been applied. It has been considered both safe and efficacious.”
WHO Director-General Tedros Adhanom Ghebreyesus announced last week that China’s Sinopharm COVID-19 vaccine has been validated for emergency use, marking the first Chinese vaccine officially recognized by the WHO.
The approval came after an extensive review by an external, technical advisor group that looked at different data, Simao added.
“We did site inspections in China in January and February… We accessed the clinical data available for Sinopharm. It was also considered suitable, and (with) efficacy and safety in good manufacturing practice,” she noted.
She also mentioned that the WHO is committed to the COVAX Facility, which is “an equitable access mechanism that we are very much working on and striving to get enough doses to be distributed.”
The official called for a change in the code of behavior, as many vaccine producers “are moving towards a profit-driven approach instead of an equitable-access approach.”
“So (the) WHO is pushing very hard at the highest level for everyone who is manufacturing vaccines to consider putting those vaccines in a global mechanism that will ensure that all countries have access to them, not only high-income countries who can pay more for the vaccines, as we are seeing as we speak right now,” Simao said.
“The code of behavior, when you talk about it, is not for vaccine nationalism. It is for everyone who has a product that can be a public health good and can help us in this acute phase of this pandemic,” she stressed.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has issued Interim recommendations for the use of the inactivated COVID-19 vaccine BIBP developed by Sinopharm/China National Pharmaceutical Group.
Who should be vaccinated first?
While COVID-19 vaccine supplies are limited, health workers at high risk of exposure and older people should be prioritized for vaccination.
The vaccine is not recommended for persons younger than 18 years of age, pending the results of further studies in that age group.
Countries can refer to the WHO Prioritization Roadmap and the WHO Values Framework as guidance for their prioritization of target groups.
Should pregnant women be vaccinated?
The available data on the COVID-19 vaccine BIBP 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.
In the interim, WHO recommends the use of the COVID-19 vaccine BIBP 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.
What’s the recommended dosage?
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 the second dose is administered less than 3 weeks after the first, the dose does not need to be repeated. 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.
Is it safe?
SAGE 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). While no differences in safety profile of the vaccine in older adults compared to younger age groups can be anticipated, countries considering using this vaccine in persons older than 60 years should maintain active safety monitoring.