According to the WHO director-general, the vaccine is considered safe, effective and quality assured with two doses.
This week, the World Health Organization (WHO) announced its approval for the emergency use of CoronaVac, a Covid-19 vaccine produced by the Butantan Institute in partnership with the Chinese pharmaceutical company Sinovac.
CoronaVac is the sixth vaccine approved by the WHO for emergency use in the context of the pandemic. The list is completed by: Pfizer/BioNTech; AstraZeneca/Oxford (which in Brazil is produced by the Oswaldo Cruz Foundation – Fiocruz); Janssen; Moderna; and Sinopharm. With this, all three vaccines currently being used in Brazil against Covid-19 now have the organization’s endorsement.
CoronaVac has been in use in Brazil since January, and more than 47 million doses have already been sent to the Ministry of Health’s National Immunization Program. Studies have shown a 51% efficacy in preventing symptoms of Covid-19, and 100% in preventing hospitalizations.
Why is the WHO approval important?
By being included in the WHO emergency list, the vaccine can also be included in Covax, a global program to provide vaccines especially to poor countries facing supply problems.
Although Coronavac has not been approved by the European Medicines Agency (EMA), an emergency listing by the WHO is a signal to local regulatory agencies that the immunizer is safe and effective. Now, it is expected that the EMA will also announce the approval of Coronavac in the coming weeks. But even if this does not happen, European Union policy should allow member countries to accept immunizers approved for emergency use by the WHO, making it possible for citizens already fully vaccinated against Covid-19 to transit with a vaccine recognized by the economic group.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.