- There is nothing unusual about Sinopharm being administered before getting the WHO SAGE approval
- Only Four Vaccines have received the WHO EUL approval
- SAGE likely to make recommendations to Sinopharm end of March or beginning of April
THE Sinopharm, Sinovac, Suptnik and at least 30 more other vaccines have submitted their dossiers to the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) for them to be listed for emergency use amidst indications that to date, only four vaccines namely the Pfizer Biotech, Astrazeneca, Mordena and Johnson & Johnson have received the Emergency Use Listing (EUL).
By Michael Gwarisa
Currently Sinopharm, Sinovac, Suptnik have been Emergency Use Approved (EUA) in their countries of origin and are currently awaiting recommendations and verification with the SAGE, an independent group made up of Clinicians, Virologists, Epidemiologists, Physicians and others who then review the dossiers that would have been submitted by the manufactures only after their national authorities would have certified or looked at their data.
Dr Lincolin Charimari, the World Health Organisation (WHO) Zimbabwe COVID-19 Response Manager told a Media Institute of Southern Africa Zimbabwe (MISA) COVID-19 reporting training that once a vaccine or medication has been Emergency Use Approved (EUA) just like Sinopharm, Sinovac and Suptnik, it can be administered in its country of origin and any other country that may want to use is also free to do so.
So all these vaccines from China, Russia, India they are being developed on an EUA basis. Now having said that, WHO has received dossiers from more than 30 different vaccine developers including Sinopharm and Sinovac. So WHO does have a Sinopharm dossier that is going through the SAGE process of approval. Hopefully by the end of March 2021 or by early April, the SAGE will give their recommendations as far as Sinopharm is concerned and as far as Sinovac is concerned. They are many others that are awaiting recommendations from SAGE to see what they will come up with.
“This is where we are in terms of Sinopharm. Because they have been approved by their own national authorities, they are being used. Sinopharm as we speak in Africa it has been deployed in Zimbabwe, Mozambique, Egypt, Senegal, Guinee. Out of Africa it has been deployed in the United Arab Emirates (UAE), Brazil and other few countries but it is still going through the WHO Emergency Use Listing evaluation process,” said Dr Charimari.
Sinopharm is one of the vaccines that are being administered in other countries including Zimbabwe and to date, a total 400,000 doses of the Sinopharm have been donated by China while the Zimbabwean government has procured 200,000 of the Sinovac vaccine to bring the total number of vaccines in the country to 600,000.
“What actually happens is that a country or a manufacturer or developer develops a vaccine and it goes through various development stages. It goes through what is called a pre-clinical phase. In other words, this is a laboratory phase where a vaccine is being tested mainly on laboratory animals and things like that. After the pre-clinical phase, it goes through the clinical trials namely Phase 1, Phase 2 and Phase 3 clinical trials.
“In Phase clinical trials, we do clinical trials with a small group of volunteer human beings, studying the vaccines, the safety profiles, studying the vaccine on what is called immunogenicity which simply refers to whether the vaccine is stimulating the person’s immune response to respond to infection by COVID-19 or to infection by whatever that vaccine is supposed to protect against. After that stage, we move on to the next stage now where a developer uses a larger group of people and move to the next stage where you are using an even larger group of people sometimes now you are doing it in more than one country. Now then it is now called a multi country study.”
After this stage according to Dr Charimari, the developer like for example Sinopharm which is developed by two laboratories in China then seeks registration of their products with their national regulatory authority in this case the Chinese Medicines Regulatory body or Authority.
“The Sinopharm Vaccine is developed by two manufactures. One is called Beijing Institute of Biological Products (BIBP). The Sinopharm vaccine that has come to Zimbabwe is coming from BIBP. So, what a developer will do since in this instant, we are talking about the Sinopharm, what BIBP will then do is that they will then seek registration of their products with their national regulatory authority.
“With Sinopharm, they will seek their registration with the Chinese regulatory authority, with Pfizer they will seek registration with the American Regulation authority, with Astrazeneca, they will seek registration with the British regulatory authority, with Mordena they will do that with the American Regulation authority etc. Their national regulatory authority, will then look through the data.
“The pre-clinical and clinical trials, the safety profiles of the vaccines and the efficacy or effectiveness of the vaccine. And if it then meets certain thresholds, it is then registered for use, BIBP for example in China they then take their papers or dossiers to the World Health Organisation (WHO) and say this is the work that we have done and this is the approval from our own regulatory authority.”
He added that WHO will not look at a developer’s dossier if its own national authorities wouldn’t have certified or looked at their data.
“In WHO, there is the Strategic Advisory Group of Experts (SAGE) which then looks at these papers and the SAGE is made up of a worldwide group of experts. These are not people who work for WHO on a day-to-day basis. These will be consultants and experts in their fields. These are virologists, these are epidemiologists, clinical physicians there is a whole range of people that make up the SAGE. They then look through these documents and then they make up their own recommendations to say that vaccine A its safety profile is like this and it has been used in people like this, it has been used in people like this and its side effects are like this and should not be recommended for use on such and such people.
“When the SAGE does that, the WHO and SAGE will make a determination on that particular profile. Now with COVID-19 vaccines there is what is called emergency use authorizations. Emergency use, because these vaccines have been developed through phase one clinical trials, through Phase 2 clinical trials. Mind you, Phase 2 clinical trials is the barest that you need for you to be then be able to say okay, we can use this vaccine. But because it has not gone through Phase 3 clinical trials, we can only approve it for use on an emergency basis.”
To date, all the vaccines that have been approved that is the Astrazeneca, Mordena, Pfizer Biotech, Johnson & Johnson have only been approved by WHO on an emergency use basis. They are emergency use listed (EUL). From the countries that they are manufactured, they are Emergency Use Approved (EUA).
“There has not yet been any case where the SAGE has not recommended a vaccine whose data would have been submitted to them. In the event that the SAGE does not recommend vaccine A, B or C and people have already been vaccinated with vaccine then what happens? Vaccines are taken to the SAGE after they have been registered in their own countries of origin. So you are taking these documents to WHO mainly to have a global approval or registration of your vaccine but you are perfectly free to use it in your own country because you have developed it and your own regulatory authority has approved it.
“And if there is person A or B who wishes to buy from your, they can go ahead and do so. It would be good to have a WHO approval but it is not necessary to have the approval for that vaccine or for that medicine to be used. There are many examples of medicines that are registered by the Food and Drug Administration (FAD) that are not registered at all by the WHO. Many of them but they are being used. So that it is,” said Charimari.
The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.
Meanwhile, uptake of the vaccines in Zimbabwe is however currently depressed owing to numerous factors chief among them being the lack of information and knowledge around the vaccines, conspiracy theories and misinformation, religious, traditional and cultural beliefs amongst a host of other factors.