Covid-19 vaccine: Local firm slams government ’gate-keeping’
Johannesburg - A local bio-pharmaceutical company has accused the government of “irregularities and systemic gate keeping” in the research and development of Covid-19 vaccine.
This comes after the national Department of Health and the Department of Science and Innovation rejected Conoché Bio-Tech’s newly-developed bio-innovation, characterising it as a traditional remedy, even though it has proven its effectiveness in neutralising various bacteria and viruses.
Iris Bajabulile Conochie, the co-founder of the Mpumalanga-based company, said the firm’s potential coronavirus pharmaceutical intervention was stymied by senior government officials despite a CSIR study having confirmed its capability to inhibit the growth of the SARS-CoV-2 virus and subsequently recommending animal and human trials in October last year.
The government has been locked in advanced talks with US pharmaceutical company Johnson & Johnson about a coronavirus vaccine deal, with local company Aspen Pharmacare having agreed to manufacture doses in the country, if it’s given the green light.
J&J’s vaccine has not yet been given regulatory approval.
According to official documents and correspondence between Conochie and senior officials from the two departments – including emails, the CSIR report and the ethics approval letter of study from North West University – Conoché Bio-Tech’s proposed collaboration and clinical studies into a potential vaccine was given the cold shoulder.
This was months after the company filed a provisional patent for an Active Pharmaceutical Ingredient that inhibits the growth of the SARS-CoV-2 virus, in March last year.
“I am writing to you regarding what I believe to be ‘irregularities’ pertaining to Covid-19, which are characterised by systemic gate keeping. I will briefly detail how our potential Covid-19 pharmaceutical intervention(s) have been stymied by technocrats and senior government officials alike: these claims can be substantiated by paper trail,” Conochie said this week.
She said her company approached the Department of Science and Innovation, in March last year, with a proposition to collaborate on generating in vivo data and conduct pharmacokinetic and pharmacodynamic studies which would have culminated in clinical studies.
“This was the first prize. Alternatively, we would have settled for funding aimed at developing these already existing potential solutions (at the time). However, our requests were met with an attitude of belittlement. Instead, we were told by a director who serves on the Health Minister’s Advisory Committee that it is highly unlikely that we have a drug that fits the criteria. Our understanding was that SARS-CoV-2 was (and still is) a novel virus: therefore, any medical intervention that can be subjected to scientific scrutiny would receive top priority.
“When we finally received the data which proved what we had been advocating for earlier in the year, we dispatched it to the relevant institutions and governmental departments. This exercise yielded the same result as that with our earlier attempt – this time with a resounding ’thanks, but no thanks’ from the director-general of Health. All the while, people were dying and are still dying,” Conochie said.
Health Minister Zweli Mkhize on Saturday reported 21 606 new cases of Covid-19, bringing the cumulative total of cases identified in South Africa to 1 214 176.
“Regrettably, we report a further 399 Covid-19 related deaths: Eastern Cape 85, Free State 11, Gauteng 69, Kwa-Zulu Natal 96, Limpopo 5, Mpumalanga 15, Northern Cape 12 and Western Cape 106. This brings the total deaths to 32 824,” the minister said.
Recoveries now stand at 956 712, representing a recovery rate of 78,9%
The national Department of Health spokesperson, Popo Maja, and his science and innovation counterpart Ishmael Mnisi failed to respond to requests for comment on Friday. Phumla Williams, the director of the Government Communications and Information System (GCIS), declined to comment yesterday, saying it was a Department of Health matter. According to a technical report by the CSIR’s Bioscience, titled “Measuring the inhibitory activity of Castor oil extract against SARS-CoV-2 and MERS-CoV using in vitro cell based assay CSIR NextGen Health Cluster Array Technology Research Group”, the castor oil tested could be declared “active against” Covid-19.
“The castor oil showed activity in vitro against the two coronaviruses tested. The ID50 of the extract was 4347 and 4695 against SARS-CoV-2 and MERS-CoV respectively. In addition, the extract did not show cytotoxicity to Vero cells used in the study as target cells (Figure 2). We found the oil’s TI against both viruses to be at least 1 000 and possibly much higher, which is desirable for drug candidates. Thus, the castor oil tested can be declared active against SARS-CoV-2 and MERS-CoV, in vitro. We would recommend animal and human trials with this oil,” reads part of the confidential report.
"The castor oil showed activity in vitro against the two coronaviruses tested. The ID50 (dose of bacteria, viruses or other infectious agents that produces infection in 50% of the test objects) of the extract was 4 347 and 4 695 against SARS-CoV-2 and MERSCoV respectively.
“In addition, the extract did not show cytotoxicity to Vero cells used in the study as target cells. We found the oil's TI (Temperature Indicator) against both viruses to be at least 1 000 and possibly much higher, which is desirable for drug candidates. Thus, the castor oil tested can be declared active against SARS-CoV-2 and MERS-Cov, in vitro. We would recommend animal and human trials with this oil."
In its Ethical Approval Letter of Study issued on November 27, 2020, the North West University granted Conoché Biotech permission to initiate the study “provided the general conditions specified below are met and pending any other authorization that may be necessary”. Conochie said her company discovered the potential Covid-19 vaccine while developing a cosmetic product.
It approached the national Health Department after the SARS-CoV-2 virus was tested by the University of Pretoria, Stellenbosch University and the South African Bureau of Standards (SABS). Despite this, both the Department of Health and the Department of Science and Innovation were not interested.
In a letter to Chonochie, of April 21, 2020, the director-general of the Department of Science and Innovation, Phil Mjwara, rejected the drug on reasons related to its efficacy.
“We note that the product you offer for validation has no clinical evidence for efficacy. We further note that market demand cannot justifiably or legally be used as a proxy for efficacy.”
He said his department consulted the experts, who told them that “for a high risk claim like either prevention and treatment of Covid-19, the requirement would be for full clinical trial evidence of efficacy and safety”.
Mjwara’s counterpart from the Department of Health, Dr Sandile Buthelezi, put the final nail in the coffin in a letter dated November 11, 2020.
“While the department encourages research into therapeutic interventions for the management of Covid-19, it does not engage in the research of investigatory therapeutics. For any therapeutic agent to be considered by the department for public use, registration with the South African Health Products Regulatory Authority (SAHPRA) is required.
“The department supports the recommendation for animal and human studies to be conducted,” he added.
Speaking to Sunday Independent yesterday, Conochie said Mjwara and Buthelezi’s assertions were unfounded.
“Although the drug is made from castor oil, when we went to characterise it we found that it contains completely different components and different units that would normally be found in castor oil. We tested it at the University of Pretoria to prove its safety for human use, testing it on liver, colon and skin cells and found that it is completely safe.
“That is why it is characterised as a drug and not traditional medicine,” said Conochie, adding that the drug was found to have antiviral properties and was also taken to the CSIR to be tested on HIV.
“So right now, we are currently facing a problem of a new Covid-19 strand in South Africa. How sure is the government that the vaccine will be effective on this strand? And yet my development is able to kill those.
“People are dying while we have a potential response to this pandemic. But because there is so much gate keeping that you can’t even move, we are being hindered from developing our discovery forward. It’s just sad.”
The government this week said it was on course to deliver vaccines and save lives.
Delivering the ANC’s January 8 Statement at the party’s Luthuli House headquarters in Johannesburg on Friday evening, President Cyril Ramaphosa said the government was planning a mass vaccine programme that would reach all South Africans.
"To overcome Covid-19 we are preparing to implement a mass vaccination programme that reaches all South Africans as appropriate quantities of an effective and suitable vaccine are procured. “This programme will initially prioritise health workers and other front-line personnel such as teachers and policemen and women, the elderly and people with comorbidities," Ramaphosa said.
He also cautioned against disinformation relating to Covid-19, as well as unfounded conspiracy theories about the virus, its treatment and the development of vaccines. "Our focus throughout must be on saving lives and protecting livelihoods."
Health Minister Zweli Mkhize said this week that the first million doses of the AstraZeneca vaccine will be delivered by the Serum Institute of India this month, and in February.
He said an estimated 1.25 million healthcare workers in both the public and private sectors will be prioritised, and that the initial million doses will arrive in January and 500 000 in February.