This article is part of our special report From vaccine race to marathon: What’s next for coping with COVID?.
A Spanish company active in animal health stands ready to start clinical trials and get the EU’s regulatory go-ahead for a ‘deadline-proof’ recombinant protein vaccine. EURACTIV spoke with the company’s chief of the vaccine programme.
Toni Maneu is the human health director of Hipra, a Spanish company developing a COVID-19 vaccine candidate. He spoke to EURACTIV’s journalists Gerardo Fortuna and Giedre Peseckyte.
HIPRA is a veterinary pharmaceutical company and it is specialised in the production of animal vaccines. Why did you decide to join the COVID vaccine ‘marathon’?
One year ago, our R&D department did a proof of a concept with a recombinant protein platform against the SARS-CoV-2 virus due to our experience in vaccines. And the results were very good, so it was a matter of responsibility to share the results with the national health authorities, the Spanish agency of medicines and medical devices (AEMPS), who told us to continue with the project.
This close cooperation with the Spanish medicine agency was the real starting point because we did not have regulatory experience in the field of human health and we wanted to follow all the guidelines needed.
This was the beginning, but what point are you at now?
We have pre-clinical results showing that our recombinant vaccine is effective against the Wuhan, UK, South Africa and Brazil variants, while we are now waiting for the results against the Indian variant, which probably will come this week.
In August, we are going to start phase one of the clinical trials followed by phase two in September in public hospitals. The rest of the clinical trials are scheduled throughout autumn in some public hospitals we have contacted in Spain, Italy, Portugal, and Malaysia – if they accept to do so.
So far, four vaccines have been authorised in Europe – two adenovirus-based, two messenger RNA (mRNA). How is this recombinant protein vaccine different?
It takes longer to develop recombinant protein vaccines but their advantage is the versatility and the capacity to adapt to new variants. That means that in a short period of time, we can adapt this second-generation vaccine to potential new variants that can lower its effectiveness.
Another advantage is that this recombinant platform is already known and used in human health. So, we are confident that we are going to launch a vaccine as safe as other recombinant proteins vaccines.
The third benefit concerns logistics as the ideal temperature for its storage is between +2 and +8 degrees Celsius, which is a significant difference compared to mRNA vaccines.
Lastly, the price will be much lower than the one of mRNA vaccines but keeping the same level of effectiveness, versatility, with the addition of a more manageable logistic. This is why some health authorities and the scientific community foresee the recombinant protein vaccines as ideal for the booster strategy.
When we started, we didn’t think about a booster strategy. The scientific community, the Spanish agency of medicines, and the hospitals told us that the most interesting thing from a research perspective would have been to conduct clinical trials with a view of entering the booster phase of the vaccine race. They told us to continue on this because, for sure, we are going to have COVID with us for a while.
At the same time, if Europe is interested in booster, other countries in the world are interested in the full vaccination programme as they have many people who have not been vaccinated yet. I recently had a conversation with Vietnam’s ministry of health and only 4% of their population is vaccinated, so they are in a very delicate situation.
How would ‘booster trials’ work?
We are starting clinical tryouts in Europe with the booster strategy. That means that the volunteers will come from being vaccinated with existing vaccines. We need two groups of people vaccinated with mRNA and adenovirus vaccines or people that have been infected previously. This will depend on the European medicines agency (EMA) or the Spanish medicine agency’s decision.
How many vaccines are you planning to produce in the following years as they are planned to be used for both: booster strategy and full vaccination?
So, by the end of September/beginning of October, we are starting the production. We expect to deliver from October to December, between 50 to 75 million doses. Depending on the demand we aim to deliver between 600 million to 980 million doses of vaccines for 2022. And in 2023, it will be up to 1.2 billion.
And how are you going to ensure that there are no shortages in the pipeline and that vaccines are delivered on time – like others? Is the vaccine you are developing ‘deadline-proof’?
I think we have learned from the experience that other vaccines had. Secondly, we already have experience with vaccine production. This amount of doses for an animal health company is not complicated: right now we are producing 24 billion doses a year in our facilities – and this number can show you our capacity.
Regarding the delivery, we have the stock already because we learned from the experience of other companies that had problems with delivery. We have a stock in advance for 2021 and 2022 and the essential materials are in our facilities in order to ensure the delivery.
[Edited by Zoran Radosavljevic]