Scientists backed the Brazilian drug regulator’s decision to stop importing Sputnik on the grounds that the batches they tested carried a live – rather than inactivated – version of the common cold-causing virus. (Illustration: Lisa Nelson)
The South African regulator has said it “will not be under any pressure” to give the green light to vaccines that have not yet met requirements for safety and efficacy.
First published by GroundUp.
Nathan Geffen started GroundUp in 2012. Previously, he was active in the Treatment Action Campaign. Michael Cherry is an environmentalist at Stellenbosch University who is interested in empowering the public to understand science. He was editor-in-chief of the SA Journal of Science and correspondent for Nature.
EFF has asked the South African Health Products Regulatory Authority (Sahpra) to approve Russian and Chinese vaccines. The more vaccines available against Covid-19 in South Africa, the better, but there are unanswered questions about these vaccines.
There are actually three Covid-19 vaccines produced in China: CoronaVac by Beijing-based company Sinovac, and two by state-owned Sinopharm. To date, Sahpra has only received requests for Coronavac, as well as the Sputnik V vaccine, manufactured by the Gamaleya Research Institute in Moscow.
How effective are these vaccines?
In a clinical trial, the Russian vaccine Sputnik V showed 92% effectiveness against Covid-19 and 100% effectiveness against “moderate or severe Covid-19”. In Chile, CoronaVac has shown 67% effectiveness against symptomatic Covid-19, 85% effectiveness against hospitalizations and 80% effectiveness against death, although these results come from a study that has not been peer reviewed.
These results are certainly promising.
But the Chilean capital Santiago imposed another lockdown earlier this month, because the cases are in strong increase, although 58% of the country’s 17.5 million people were fully immunized and 75% received at least one dose of the vaccine. Chile’s vaccination program primarily uses the CoronaVac.
Similar experiences are reported Bahrain, Seychelles and Mongolia, all countries that have used vaccines mostly made by the two Chinese producers. According to New York Times, these four countries are “ranked among the top ten countries with the worst Covid epidemics no later than last week ”.
These outbreaks raise troubling questions about CoronaVac, but that doesn’t necessarily mean it’s not useful; it can still prevent infections and death.
Concerns about Sputnik V
Concerns about Sputnik relate primarily to his security.
Sputnik uses an adenovirus vector – in this case, a modified version of the common cold-causing adenovirus to carry the spike protein genes in the coronavirus as a means of priming the body if it encounters Covid-19.
This is similar technology to the vaccine developed by AstraZeneca, but unlike AstraZeneca’s two-dose vaccine, the Russian approach uses a slightly different adenovirus for the second booster, so the two doses are different and not interchangeable.
The safety issue concerns the adenoviral vector. Scientists have supported the Brazilian drug regulator’s decision to stop importing Sputnik on the grounds that the batches they tested carried a live – rather than inactivated – version of the common cold-causing virus.
Again, that doesn’t mean Sputnik isn’t a good vaccine, but questions about the quality of its production need to be answered.
Ethics: Deploy vaccines before they are properly tested
An established ethical principle in medicine is that a product is not put on the market until it has been tested properly, usually in a large clinical trial where volunteers are closely monitored and randomly assigned to receive the new drug or drug. vaccine against, generally, a placebo. .
Yet Russia began deploying Sputnik V long before evidence of its effectiveness was released.
China was also critical for vaccine deployment without sufficient transparency on clinical trial data.
This does not disqualify these vaccines for use here, but it does show that Russia and China have an approach to medical ethics that is not working in South Africa.
This is not western chauvinism: transparency matters
The reality is that the vaccines produced by the big pharmaceutical companies in Europe and the United States – AstraZeneca, Johnson & Johnson (Janssen), Moderna, Pfizer and Novavax, inspire more confidence. Their data has been reviewed by the US Federal Medicines Agency (FDA) or the European Medicines Agency (EMA), along with their production facilities.
Despite some valid criticism, the FDA and EMA are to a much greater extent independent of political interference than their counterparts in Russia and China. They have proven themselves and operate in democratic countries where the leader of the country does not call all shots.
One example is the FDA forcing Janssen not to use millions of doses made in a US factory due to a production problem. Unfortunately, this has resulted in a shortage of South Africa’s estimated vaccine supply.
The problem with the Janssen vaccine in the United States has been identified precisely because the FDA is generally independent and competent. Would similar problems in China or Russia be detected?
Sahpra must decide without undue pressure
It is Sahpra’s task to assess the quality, safety and efficacy of vaccines used in South Africa. It must act only in the public interest, free from undue pressure.
Apparently, Sahpra’s evaluation of the CoronaVac app is at an advanced stage, and reports recently made available by the World Health Organization justifying its recent emergency use list are under review. The Sputnik V application is subject to what is called continuous review: as data becomes available to the requester, it is submitted to Sahpra.
CEO of Sahpra, Dr Boitumelo Semete-Makokotlela mentionned: “Sahpra will not be pressured to allow public access to any product that does not meet the necessary regulatory requirements.”
In the meantime, we have two good quality vaccines in use in South Africa: Pfizer and Jannsen. We should also try to get the Moderna, Novavax and AstraZeneca vaccines.
And, yes, if Sahpra is satisfied that the questions on Sputnik and Coronavac have been answered satisfactorily, we can still proceed with their use. But neither the EFF nor any political party should push the regulatory authority to make a dangerous decision. DM
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This notice was published: 2021-06-23 14:48:18