The “vaccine” Ekurhuleni mayor is hoping to buy from a Cuban-Chinese company isn’t a vaccine. It’s a drug — and it’s not proven to work against the virus that causes COVID-19.
Applause erupted during Ekurhuleni’s state of the city address, about 10 days ago, after mayor Mzwandile Masina announced that he would be using the city’s emergency funds to procure a coronavirus vaccine.
No such vaccine exists yet.
The “vaccine” Masina referred to, was a drug called interferon-alfa-2B, manufactured by joint Cuban-Chinese company ChangHeber. The medication is registered in South Africa for the treatment of skin cancer.
Masina announced Ekurhuleni was procuring the medicine in consultation with Gauteng’s Health MEC Bandile Masuku.
Earlier that day, at a provincial government briefing, Masuku endorsed the procurement of the Cuban-made drug as treatment for patients with COVID-19.
While it is unclear where Masina heard of interferon-alfa-2B, Masuku acknowledged the source as a statement issued the day before by the workers’ trade union, NEHAWU.
NEHAWU claimed that the medication “has cured more than 1 500 patients from the [SARS-CoV-2] virus and has been used by the Chinese National Health Commission to combat respiratory diseases”.
None of this made scientific sense.
There is no evidence that interferon-alfa-2B, or any other drug, work to treat COVID-19, and according to the World Health Organisation (WHO), to date, “there is no vaccine and no specific antiviral medicine to prevent or treat COVID-19”.
At a briefing the day after Masina’s city address, South Africa’s Minister of Cooperative Governance and Traditional Affairs, Nkosazana Dlamini-Zuma — a medical doctor — confirmed that there is no vaccine for the new coronavirus virus.
She concluded: “We are looking at maybe 18 months before we can say we have a vaccine so there is no vaccine.”
Masina was confusing interferon-alfa-2B, for which there was also no proof as treatment for COVID-19, with a new coronavirus vaccine.
What is interferon-alfa-2B — is it even safe to take?
Interferons, a group of proteins, are naturally produced as a way for the body to fight off viral infections. There are three different types — alpha, beta and gamma — based on which cells produce them, but all are antivirals (in other words, they fight off viruses), according to a 1994 paper in Antiviral Research.
But there is no evidence that interferons work to treat COVID-19.
In fact, there are serious safety concerns about ”exactly when or even if to use interferons in COVID-19 treatment”, warns Andy Gray, a pharmacy expert from the University of Kwazulu-Natal.
“[Interferons] might in fact make things worse because they might exacerbate the immune response and then that way create more organ damage,” he says.
The use of interferon, either on its own or in combination with ribavirin (an antiviral medication used to treat hepatitis C), caused significant lung damage in patients being treated for hepatitis C, according to a 2002 study in The American Journal of Gastroenterology. One effect of the medication was interstitial pneumonitis – where your lungs become inflamed causing difficulty breathing.
The latest coronavirus outbreak began with a group of people who had pneumonia but the cause was unknown.
There is some evidence that interferon beta worked as a treatment for Severe Acute Respiratory Syndrome (SARS), another coronavirus-related outbreak in 2003 which, like SARS-CoV-2, also originated in China. But the treatment only worked in vitro, in other words, in cells rather than people, according to a 2003 study published in The Lancet. The interferon treatment was never tested in a controlled clinical trial with people.
Gray explains: “Even if there are medications that work in cells, that doesn’t necessarily mean that they will work if you try and give them to patients. There are a lot of differences between how something interacts in a cell in a petri dish versus how it interacts with someone’s body.”
“When it comes to testing drugs in human trials, the failure rate is high.”
Interferons have also been tried out as a treatment for Middle East Respiratory Syndrome (MERS), a coronavirus-related outbreak first reported in Saudi Arabia in 2012. But research published in the Journal of Infection and Public Health in 2018, found no conclusive data on the effectiveness of interferons by themself as treatment for such patients.
Gray says that even if medication proved to be an effective treatment for another coronavirus outbreak, like SARS or MERS (interferon-alfa-2B wasn’t consistently effective), that still wouldn’t guarantee it would work for COVID-19.
“It gives you more of an indication of sort of efficacy and safety but this is a slightly different virus,” he says.
“Most of the COVID-19 cases are mild and resolve on their own. Due to the nature of the virus, it’s difficult to tell if giving medication to some patients helps them recover or if it’s just the virus passing on its own.”
No, the World Health Organisation does NOT recommend this treatment
So why would government officials then be procuring interferon-alfa-2B to treat COVID-19 patients?
Kwara Kekana, spokesperson for Masuku responded: “The medication has been used for specialized patient treatment as is, under the guidance of specialists in SA.”
“[It] has antiviral properties.”
Kekana says doctors in Gauteng will use guidelines as set out by the World Health Organisation (WHO).
But the WHO doesn’t recommend interferons as treatment.
The national department of health did not respond to questions on guidelines for treatment or comment on the endorsement of an interferon treatment at the time of publication.
The mayor’s ‘vaccine’ and the curious case of Cuba
Despite not having any evidence of interferon-alfa-2B as an effective treatment for COVID-19, NEHAWU said in its statement: “The Cuban pharmaceutical industry gave a guarantee on Saturday [14 March 2020] that the production of the 22 drugs used for the treatment of COVID-19 including Interferon Alpha 2B has been proven to be very effective in fighting the virus.”
This information was also published in the Cuban state-owned newspaper, Granma. The media outlet also published that the medication had cured 1 500 patients with the virus in China, despite there being no proof of this.
This guarantee is said to have come from the pharmaceutical group, BioCubaFarma. But there is no information on their website about any of the medications or how it was proven that they work against the new coronavirus.
As of Thursday, 26 March, Cuba had 57 confirmed COVID-19 cases. Cuba had seen its first case three days prior to when BioCubaFarma reportedly confirmed the success of interferon as a treatment.
Several media houses reported that some doctors in China have tried out the medication on COVID-19 patients, but official documents online are not clear about this.
Guidelines published in Military Medical Research at the beginning of February said the use of interferon could be considered as a treatment along with a combination of HIV antiretroviral medications lopinavir and ritonavir. However, these are listed as weak recommendations. The research was done by a team at Zhongnan Hospital of Wuhan University, China.
In the paper, they acknowledge that “combined use of antivirals is still controversial”.
The drug is registered in SA — but not for Covid-19
In South Africa, all drugs must be approved for use in the country by the South African Health Products Regulatory Authority (SAHPRA). This also applies during a state of disaster, as we currently have with COVID-19.
If a medication is not approved by SAHPRA, that decision is final and not even the health minister could override it.
In the case of interferon-alfa-2B, SAHPRA would require a randomised controlled clinical trial showing it can treat patients with COVID-19.
“All COVID-19 projects will be expedited within a timeframe of, at most, a month, once an application with the relevant data is submitted to SAHPRA,” explains SAHPRA spokesperson Yuven Gounden.
The interferon drug that Masina spoke about is already registered for use in South Africa as a cancer treatment. The United States pharmaceutical company, Merck, is authorised to distribute it.
If someone wants to use an unregistered drug, the medication will have to be sourced from another country through the manufacturer.
SAHPRA has a separate approval process for the use of unregistered medication, where doctors must motivate why they cannot use an alternative. A patient receiving an unlicensed treatment must also sign a consent form acknowledging the process.
For interferon-alfa-2B, Masina would also have to justify why the medication has to be sourced from Cuba when a registered alternative already exists in the country.
While interferon is not an approved or recommended treatment, if a doctor was able to justify giving it to a COVID-19 patient, then they would be able to use the Merck-produced interferon as opposed to waiting for approval to source the same drug from Cuba.
But it would be hard to get approval for use of interferon-alfa-2B without scientific evidence that the drug is of benefit, or safe to use, for COVID-19 patients.
‘If we break the rules, that can come back to bite us’
On Wednesday, 18 March, the WHO announced it would be launching a large-scale, international study in partnership with 10 countries, including South Africa. This trial, called Solidarity, will be testing four different treatment options for Covid-19 — one of which is a combination of the antiretroviral drugs ritonavir/lopinavir (the drugs are used as HIV treatment) and interferon-beta. This drug combination is also being tested as a treatment for MERS.
During a global pandemic or outbreaks of this scale, there is a rush to test vaccines and roll out treatments as quickly as possible to save more lives. Gray recalls a similar scenario with the H1N1 influenza pandemic in 2009, where people who received a vaccine called Pandemrix were more likely to develop narcolepsy.
“You still have to be cautious about what it is that you need and not to take things that arrive from anywhere that might in fact do more harm than good so the medicines regulatory authority will still be very important,” he says.
“When we’re in a pandemic and a crisis and we break the rules to some extent, sometimes that can come back to bite us.”