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Vaccines go through several different stages from the moment they are formulated until they hit clinic shelves. The most complicated phases involve actually creating the vaccine solution. (Photo: Daniel Schludi, Unsplash)
South Africa is set to produce its first vaccine in 25 years, but it will not be a Covid-19 vaccine. However, there are plans to ‘fill and finish’ Covid-19 vaccines in South Africa.
Aspen Pharmacare will not produce Johnson & Johnson’s Covid-19 vaccine in South Africa. Instead, Aspen will be one of six sites globally responsible for putting the vaccine into vials and packaging the jabs for distribution, Johnson & Johnson Chief Scientific Officer Paul Stoffels confirmed late Tuesday.
Vaccines go through several different stages from the moment they are formulated until they hit clinic shelves. The most complicated phases involve actually creating the vaccine solution. The last and final stage, in which the prepared vaccines are filled into vials and packaged for delivery, is often referred to as “fill and finish.”
No plant in South Africa has produced a vaccine on its own in 25 years, says Biovac Institute executive director Dr. Morena Makhoana. Biovac is a public-private partnership created in 2003 to revive vaccine production in South Africa after the country stopped producing vaccines locally in the 1990s.
Instead, Aspen and Biovac have historically focused on obtaining and distributing jabs or filling and finishing them, as Aspen will with the Johnson & Johnson vaccine candidate. The duo are the only two companies working locally in the field of vaccines.
Stoffels explains that building a new Covid-19 vaccination capacity in South Africa and elsewhere would have taken three to five years. Instead, to quickly meet demand for the vaccine, Johnson & Johnson will produce the vaccine at three existing plants before shipping it to six centers around the world, including the Aspen factory in Port Elizabeth, for filling and finishing.
Johnson & Johnson’s Covid-19 experimental vaccine is in the final stages of human trials, including trials in South Africa. Stoffels says the firm hopes to know by the end of January 2021 if the jab works to protect people from becoming infected with the new coronavirus or from developing severe Covid-19 disease.
Stoffels says that about half of Johnson & Johnson’s costs to develop its Covid-19 vaccine have been covered by the United States government, which is one of the reasons the firm will offer the vaccine. at cost during the emergency phase of the pandemic. It has also reserved 500 million doses for the COVAX initiative.
Could South Africa Produce a Covid-19 Vaccine?
exist nearly 350 experimental Covid-19 vaccines in development, according to the UK scientific analysis company Airfinity. The World Health Organization (WHO) says only about four dozen bumps have entered human clinical trials.
Airfinity CEO Rasmus Bech Hansen says that Covid-19 vaccines fall into one of four main categories. Some injections like the Johnson & Johnson vaccine use harmless viruses to transport proteins to the body and, hopefully, trigger an immune system response. Others, like the Novavax vaccine tested by the University of Wits, pair sterilized coronavirus proteins or protein parts with an immune booster to help the body create antibodies that fight Covid-19. This type of vaccine is sometimes called a protein subunit injection.
Executives at Aspen and the Biovac Institute say their companies could one day produce three of the four main types of Covid-19 vaccines.
Aspen CEO Stephen Saad said Highlight that its Eastern Cape plant could eventually make vaccines, such as Johnson & Johnson’s FCovid-19 experimental vaccine, often referred to as “viral vector” vaccines.
Biovac, meanwhile, could potentially one day produce Covid-19 injections like Novavax, as well as the Pfizer / BioNTech vaccine, which uses genetic material produced in laboratories trick the body into believing that the coronavirus is present and develop an immune response.
The Coalition for Innovations in Epidemic Preparedness (CEPI) is working to ensure access to vaccines for the poorest countries through an initiative called COVAX. CEPI has identified Biovac as a possible vaccine producer, but has not reached any formal agreement with the institute, CEPI said. Highlight.
In reality, producing a Covid-19 vaccine on local soil will mean that larger pharmaceutical companies, like Johnson & Johnson, will have to share some of their knowledge about vaccine manufacturing with local companies, a process called technology transfer.
There is no quick and easy path to local production
The Biovac Institute has taken almost 20 years to produce a vaccine from start to finish in the country. It can take three to five years and up to R8.9 billion to build plants to produce certain types of vaccine solutions. and Makhoana says funding has been a problem.
But Biovac announced in November that it would soon begin locally producing the six-in-one vaccine from pharmaceutical firm Sanofi Pasteur to protect children against diseases such as polio, tetanus and hepatitis B.
The move follows eight years of working with the vaccine’s developer, Sanofi, to transfer the technology needed to produce the six-in-one jab in South Africa and for the local market, Makhoana says.
Johnson & Johnson has signed a technology transfer agreement with Aspen to fill and finish its Covid-19 vaccines. Aspen declined to reveal details about the deal.
However, Candice Sehoma, an advocacy officer for the Médecins Sans Frontières (MSF) access campaign, says the deal is more of a manufacturing deal than a significant technology transfer that would bolster local production. And, he says, the deal may not guarantee South Africa better access to the Covid-19 vaccine.
“Yes, Aspen will handle the filling and finishing, but in the end, Johnson & Johnson still has the intellectual property rights to that vaccine. They can determine who, where and how their vaccine is distributed, ”he said. Highlight. “Knowing that high-income countries have secured most of the [world’s] vaccines, it really leaves a lot of doubt as to … whether what is being filled and finished locally will benefit South Africa and the continent. ”
the The United States, the European Union and India alone purchased more than four billion doses of Covid-19 experimental vaccines before any jab was shown to work, according to an analysis by Duke University in the United States.
A showdown over Covid-19 patents expected at the World Trade Organization
Meanwhile, South Africa and India have submitted a joint proposal to the World Trade Organization (WTO) that would allow countries to renounce some intellectual property rights on medicines, vaccines, masks, fans and other materials for the duration of the pandemic. Some similar provisions already exist in international trade law, but they are difficult to apply in practice.
However, the WHO-backed proposal, which is expected to be discussed at the WTO on Thursday, faces strong opposition from countries and the pharmaceutical industry.
The United States, the United Kingdom and Japan, which were among the first countries to buy massive quantities of Covid-19 vaccines, were among the nations that opposed the patent exemption in October.
Stoffels says there are more immediate barriers to expanding access to Covid-19 vaccines than technology transfers or patents. He explains that it has been difficult to even ensure that Johnson & Johnson’s manufacturing plants have the new technology necessary to produce its experimental Covid-19 vaccine.
“We are developing a new production technology and expanding [production] all at the same time, ”he says, adding that the technology is still evolving. “We don’t even have enough people to do our own technology transfers to our own manufacturing facilities. We had to find the people, ”he says.
“Maybe there is time to [that kind of tech transfer] in the next five to 10 years, but for now, we are focused on getting the technology stable to make sure we can deliver next year. ”
But speaking earlier this year, MSF Access Campaign Senior Vaccine Policy Advisor Kate Elder says she believes the world can scale up vaccine manufacturing while removing barriers related to vaccines. patents for future production.
“Nobody has the naive pretext that if there is no intellectual property, everyone will be able to produce vaccines,” Elder said in October. “Let’s be clear: it is difficult to develop vaccines and it is difficult to manufacture them … but there is tremendous capacity in places like India and Brazil,” he said.
“It can expand manufacturing capacity and [ensure] Intellectual property barriers are not an obstacle for any manufacturer that has the ability to produce future quality-assured Covid-19 vaccines. ”
Airfinity predicts that access to vaccines will help curb outbreaks in the United States in March, followed by Canada, the United Kingdom, and the European Union by the end of next year. India and China are expected to follow suit in 2022.
“There is more uncertainty in the rest of the world,” says Bech Hansen. “It really depends on the results of the upcoming tests and the availability of large-scale production facilities.” DM / MC
Note: Section27 is a member of the Fix the Patent Laws campaign and has supported measures such as the intellectual property exemption mentioned in this article. Spotlight is a publication of Section27 and Treatment Action Campaign, but it is editorially independent – the independence that the editors jealously guard. Spotlight is a member of the South African Press Council.
This article was produced by Highlight – Public interest health journalism. Sign up for our newsletter.
