World’s first fully liquid vaccine to be locally manufactured by CT-based Biovac

  • SA company Biovac announced that it will be manufacturing Sanofi Pasteur's six-in-one paediatric vaccine, Hexaxim
  • This hexavalent vaccine aims to protect against leading childhood diseases, including polio, diphtheria, and tetanus
  • Biovac will be producing four million doses of the vaccine annually

Cape Town-based bio-pharmaceutical company Biovac has begun local manufacturing of global pharmaceutical company, Sanofi Pasteur’s six-in-one paediatric hexavalent vaccine, Hexaxim. 

This is the world’s first fully liquid vaccine. It was introduced in South Africa in 2015 where Biovac was labelling and packaging the vaccine. It has now been approved by the South African Health Products Regulatory Authority (SAHPRA) for manufacturing under sterile conditions. 

It is one of the most complex combination vaccines in the world and aims to protect against six leading childhood diseases: diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type B and poliomyelitis, the company announced during a virtual webinar on Thursday.

“Biovac is extremely proud to be able to commence local manufacture of one of the most complex combination vaccines, globally. It is indeed a historic moment, not just for Biovac, but for the country,” said Biovac CEO, Dr Morena Makhoana.

This is the first time since the mid-1990s that any sterile manufacturing of human vaccines has been done in South Africa, and is also the first technology transfer of such a product from Sanofi Pasteur to an external partner. 

“This vaccine is the answer to a busy, working caregiver, mother or father,” said veteran journalist Redi Tlhabi, who moderated the webinar, calling it a “gift” to be able to arrive at a clinic and have one’s child receive the hexavalent vaccine. 

Why is this product unique and significant?

Combination vaccines come with multiple benefits, such as reducing the risk of needle stick injuries associated with multiple injections, increasing compliance, and reducing the cold chain requirements needed in healthcare facilities.

The vaccine was introduced into the Department of Health’s Expanded Programme of Immunisation (EPI) since 2015, and over five million infants have received the vaccine to date.

Since the hexavalent vaccine does not need to be mixed before injection, it is easier to administer in remote and resource-poor health settings.

Currently, it is a key vaccine in the national immunisation programmes in eight countries, including Mexico, Saudi Arabia, Belgium, Chile, and South Africa.

“This vaccine essentially covers nine antigens [if you consider Polio 1, 2 and 3]. It is extremely complex and is the first product to have achieved this, and it’s quite important for us to understand that to combine all of the nine and make sure that they live in harmony in a fully liquid vial that can be stored at two to eight degrees Celsius is extremely important, and Sanofi was the first to achieve this,” said Makhoana . 

The product has 50 manufacturing steps, 223 analytical methods (various tests), and 1 277 individual tests – all of which has to be completed before the product can reach a clinic. 

"The partnership will ensure that we contribute to the wider manufacturing capabilities in order to allow for new opportunities to open up going forward," Makhoana said, further commenting: 

“Biovac will be producing four million doses of the vaccine annually. It’s one of the largest vaccines when you look at the volume that it actually occupies."

Africa does not have much vaccine manufacturing capability

Makhoana touched on human vaccine manufacturers on a global scale, noting that Africa does not have much vaccine manufacturing capability relative to other continents. 

“It is quite unfortunate that this gap still exists in Africa, but this is a small way that Biovac are attempting to plug the gap. We are the first modern vaccine manufacturer. 

“We do have colleagues in Senegal, Egypt and Tunisia, but we have been reviving vaccine manufacturing and we are very proud to be the first to sign up with a global partner on the continent. Not much has been happening in the country for the past 20 years.

“We need a lot more manufacturing capability, and not only Biovac. We need others to come to the party. It’s important that we are able to better respond to the next pandemic. But the [African] continent in general, should really just wake up and say: ‘How are we going to be not just a consumer, but also a manufacturer of vaccines?’”

Sanofi Pasteur Head of Commercial Operations, Stephen Alix also commented:

“Vaccines are a critical public health need and although South Africa is a developing economy, its public vaccine schedule is robust and world-class. Production and supply of vaccines are quite sophisticated, especially for the six-in-one combination vaccine, as a single vaccine may take up to 36 months to be manufactured,” 

Dr Blade Nzimande, Minister of Science and Innovation who attended the webinar also referred to the partnership as "a very historical occasion for our country and our continent in particular".

“The clinical trials we are very proud to say were conducted in South Africa, and the vaccine was licensed in 2014. This development lays a very important foundation to build our own capacity as a country, and for the benefit of the continent,” Nzimande said.

The importance of immunisation

“Immunisation is, just after water sanitisation, the most efficient public health asset,” Alixc commented.

“The significance of immunisation is obvious. The WHO estimates that it saves up to three million lives every year. However, despite all the efforts to continue bringing vaccines to all the children in the world, in 2016 it was assessed that one in 10 infants worldwide did not receive a single immunisation.

“So today we are celebrating this huge milestone. We are also working very hard with Biovac and the Department of Health to continue striving for increasing and improving the coverage rate.

“And routine immunisation is even more crucial during a pandemic because we need to keep preventable diseases at bay while resources are redirected to managing and continuing the Covid-19 crisis faced by countries."

Partnership between Sanofi and Biovac

Alix also explained the importance of long-term commitment and partnering with governments and stakeholders, in that they are imperative to ensure sustainability of vaccines.

“The strategy for South Africa and Africa is to work with our partners and governments to increase vaccine coverage by ensuring that every child is vaccinated against vaccine-preventable diseases,” he said.

Sanofi has been working with the WHO/GPEI for polio eradication since 1982.

Alix explained that, globally, South Africa is the leading country in the utilisation of this type of vaccine. 

“With very few partnerships of this nature, Sanofi Pasteur’s technology transfer to Biovac is for the most innovative vaccine globally,” he said.

READ | Why Africa is lagging behind with child vaccination

READ | Covid-19: No deal yet to access '90% effective' vaccine tested in South Africa

READ | Routine childhood vaccine benefits outweigh Covid-19 risks, study finds

Image: Pexels/Thirdman

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