It takes about Ksh.100 billion and 7 years to develop a vaccine – KEMRI
Did you know that manufacturing a vaccine that could be widely and safely used by human beings of different genetic makeups could cost nearly one billion dollars which translates to nearly Ksh.100 billion and at least seven years of trials before it is commercially viable?
This revelation by Dr. Bernhards Ogutu of the Kenya Medical Research Institute (KEMRI) puts into perspective the sheer cost of trying to manufacture a vaccine and why many vaccines come into the market as a result of collaboration between donors and governments.
Even though Kenya has had a long history of vaccine use, one thing that never changes is the hesitance and distrust towards these medicines.
Kenyan scientists in collaboration with foreign organizations have been at the forefront of clinical studies for various vaccines since the 1990’s. During that period clinical studies on vaccines for Malaria, HIV/AIDS, Polio, Ebola and Pneumonia, have been carried out in Kenya through KEMRI and for some volunteer vaccine trials have been carried out.
Dr. Ogutu has been involved in the Malaria vaccine roll-out which is currently being administered to eligible children in eight counties in a phased manner. The clinical testing was done in Kenya before Kenyan authorities approved the use of the vaccine.
“The roll-out is going very well. We are pleased with the results so far,” says Dr. Ogutu.
He outlines the benefits for any country that gets involved in the pilot studies or clinical trials of a virus.
“It gives greater bargaining power for that country to get the commercial virus when it is ready and you know that the vaccine will work in your country,” he adds.
Vaccine development is a laborious and lengthy process that few countries can manage on their own. On the African continent, only South Africa, Senegal, Egypt, Morocco and Ethiopia manufacture vaccines and when it comes to developing a vaccine from scratch, the process could take at least 7 years with a price tag of Ksh.100 billion.
“It is a long process with so much to work on and without collaboration then this will not be possible,” adds Dr. Ogutu.
Kenyan scientists are involved in global studies on vaccines for several diseases and according to Dr. Bernhards Ogutu, from time to time they get requests to study the data of a particular vaccine in trial.
So should a Kenyan scientist receive a request to study the data on a potential Covid-19 vaccine, then the first step will be to study that data in collaboration with fellow scientists for verification and to give feedback.
If convinced that the vaccine is viable, the scientist can submit the data to a scientific and ethics review committee at KEMRI that will give recommendations.
Finally if the vaccine’s data faces no challenges, then the Ministry of Health and Pharmacy and Poisons Board will form a committee of experts to probe the data further. Only after those three stages of approval can a Kenyan scientist begin to advertise or recruit volunteers for the study.
“So it is not a foreigner that will come to test our people. Rather we are the ones who collaborate with others to seek solutions to problems that challenge our people. They come to us because we have the local capacity to assess the vaccines. I am currently receiving requests to check data for a Covid-19 vaccine and we are giving feedback,” says Dr. Ogutu.
Prof. Omu Anzala, a virologist and immunologist at the University of Nairobi, has been involved in the search for an elusive vaccine for HIV/AIDS for the last 20 years in conjunction with the University of Oxford and he is quick to counter the widely-held perception that African volunteers are guinea pigs for foreign vaccine manufacturers.
“Trials were not carried out in Kenya since before 2011. Tests started recently and are done in a structured manner,” says Prof. Anzala.
He walks us through the four stages of human vaccine trials that the Covid-19 vaccine could be subjected to. Note that the several stages of testing prior to this happen on animals which have immune systems similar to human beings.
The first stage of human trials seeks to answer the question on whether the vaccine is safe and it is carried out on 30-50 volunteers over a one-and-half years period.
The second stage is extended safety and immune response testing carried out on 100 – 150 volunteers over one to three-year period. The third stage is efficacy testing which could take four to five years and involve 2000 — 5000 volunteers.
And the final stage of testing looks at the effectiveness of production of large doses of the vaccine and the supply chain and logistics factors.
“It is an expensive process which no government can handle on its own. Conspiracy theories will only work against us,” adds Prof. Anzala.
He, however, admits that the vaccine sector lost some credibility with the polio debacle where a child died in Limuru in 2015 and a case in early 2018 where one child died and four others were paralyzed after a measles vaccination exercise.
“These incidents have caused us challenges with lobbyists but you have to look at the greater good,” he says.
According to the World Heatlh Organziation, Africa, which accounts for 14% of the world’s population, only participates in 0.1% of the world vaccine population.
Prof. Anzala believes that Kenya can rise up and become a hub for vaccine development.
He warns that unless African countries engage in the Covid-19 vaccine trials, then when the vaccines finally hit the market they will not have factored in the multi-faceted African DNA and may prove useless for Africans.
There are currently several Covid-19 vaccine development processes happening around the world with President Uhuru Kenyatta stating that Kenyans will not be used as guinea pigs for vaccine tests but will instead focus on a global vaccine effort that KEMRI and other African organizations are a part of.
Kenyatta made the remarks after BBC’s Medical Correspondent Fergus Walsh said during an interview that a team of scientists from Oxford University were working on a coronavirus vaccine which will be tried in Kenya if they don’t get early quick results in the U.K.