Covaxin Gets EUL Approval from WHO: 5 Things to Know
India's Covaxin COVID-19 vaccine gets WHO approval. What does it mean? What changes? Here are 5 questions answered.
Bharat Biotech's COVID-19 vaccine, Covaxin has been granted Emergency Use Listing (EUL) from the WHO, on 3 November.
The World Health Organisation's decision comes after a long and scrutinous review.
Covaxin is also India's first home grown vaccine to make it to WHO's list of approved COVID-19 vaccines.
What this means is that those who have received Covaxin, will finally be recognised internationally as vaccinated.
In the twitter thread, WHO goes on to say, "The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the #Covaxin vaccine meets WHO standards for protection against #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used (worldwide)."
Here are five big questions about the approval and Covaxin's status now, answered.
I have taken two doses of Covaxin COVID-19 Vaccine. Am I considered fully vaccinated?
Yes. The WHO approval is a sort a stamp of validation given by the WHO to vaccines after a thorough review to determine their safety and efficacy.
In their announcement, WHO also stated that Covaxin was found to have a 78 percent efficacy against COVID-19 of any severity, 14 or more days after the second dose.
Who is it approved for?
According to the WHO's announcement, Covaxin is approved for people over the age of 18.
The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), recommends 2 doses of the vaccine be taken with an interval of four weeks.
Is there any subgroup of people it is not recommended for?
In WHO's tweet they also mention that the vaccine is not recommended for pregnant women.
The reason they cite is that there isn't sufficient data to assess the safety and efficacy of the vaccine in pregnant women.
In a live interview shortly after the announcement, Dr Joachim Hombach, Executive Secretary of SAGE acknowledged the lack of data for the safety and efficacy of the vaccine in pregnant women.
However, he also added, "we are also recomending the use of the vaccine to pregnant women on the basis of a benefit risk assessment."
I have taken the Covaxin COVID-19 vaccine. Does this mean I can travel abroad now?
The WHO approval is essentially a certification of validation from the WHO which tells other countries (where Covaxin is not in use, or assessed) that it is safe, and efficous by the WHO's standards.
But, again, each country has its own EUL or the list of COVID-19 vaccines it recognises.
For instance, Australia had added Covaxin to its list of recognised vaccines for travellers just a couple of days ago before WHO's announcement.
The WHO approval will definately help Covaxin's case when it comes to recognition and approval in individual countries going forth.
Moreover, when it comes to travel restrictions, many countries like the US allow all WHO approved vaccines– which means those who have received Covaxin will now be allowed to travel to the US.
What changes for Covaxin?
For one, the WHO EUL will pave the way for countries to add Covaxin to their list of recognised vaccines for travellers, which means ease of international travel for recipients of Covaxin in the near future.
This could, particularly, mean a huge sigh of relief for students and migrant workers who have been locked out of other countries because Covaxin wasn't recognised internationally.
Moreover, according to WHO, its "EUL procedure assesses the quality, safety and efficacy of COVID19 vaccines and is a prerequisite for COVAX vaccine supply."
Now that the review has found the vaccine to be "extremely suitable for low- and middle-income countries due to easy storage requirements," it means that Covaxin can now be distributed to these countries as part of the COVAX initiative.
In a press statement responding to the WHO approval, Dr. Krishna Ella, Chairman and Managing Director, of Bharat Biotech said,
"The EUL authorisation for COVAXIN will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency.”Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech
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