China's Approval of mRNA Vaccine 'in Final Stage'; Effective Against Over 30 Variants Including Indian One: BioNTech CEO

Promising path to protection

By Hu Yuwei

May 06, 2021 08:03 PM

Editor's Note: The innovative BioNTech-Fosun mRNA vaccine BNT162b2 (known as BioNTech-Pfizer vaccine in the West) has been widely used in over 65 countries and regions across the world so far, while its potential green lighting in the Chinese mainland has attracted much attention as it could be the mainland's first imported vaccine against the coronavirus disease given its promising efficacy. The Global Times reporter Hu Yuwei (GT) recently talked exclusively to the German-based vaccine developer BioNTech's CEO, Ugur Sahin (Sahin) who expressed his strong confidence in the marketing prospects of the vaccine in China. The approval has entered the final stage in the decision-making processes, and the co-developer's conversation with Chinese authorities is very "encouraging," said Sahin.

Safety and efficacy improvements

GT: We know from news reports that there have been several cases of deaths linked to vaccine shots in some EU countries that have raised public doubts about the safety of the vaccine. What do you think about these deaths? How do we scientifically understand the risks of a vaccine?

Sahin: It is extremely important to deal with that in a transparent fashion. We did one of the largest clinical trials involving over 46,000 participants and we published the data which show that our vaccine is generally well-tolerated in all populations. 

One important aspect is that we have started vaccination in elderly people, who often have further comorbidities such as diabetes. We see classical moderate side effects of the vaccine e.g., pain on the injection site and fever which are well-known symptoms related to all kinds of vaccines. In addition, we are investigating the reports of all side effects. 

Safety is of utmost priority for us. We monitor our vaccine very closely and have employed safety surveillance systems in collaboration with our partners to provide ongoing safety monitoring.

GT: Mutations of the coronavirus disease have been discovered in multiple places around the world. How is BNT162b2 effective against the mutant coronavirus disease strains discovered so far? Are you preparing to upgrade the vaccine to deal with the mutations? How long does the development and production process for vaccine upgrades take?

Sahin: We are continually monitoring various virus variants with new mutations, and we are testing the efficacy of our vaccine against various prevalent virus mutations using the sera of vaccines. We did that for more than 30 variants including those from Britain, South Africa and India.

So far, we found that our vaccine is able to neutralize all variants in almost the same manner. In addition, we have real-world data indicating that our vaccine also provides protection against asymptomatic SARS-CoV-2 infection. 

If a strain were to arise that is not adequately tackled by our vaccine, we could adapt the sequence of our mRNA and start with a different DNA template for this variant, but this needs to be approved.  

Once it is approved, we could provide a new vaccine within about 3 months.

GT: How long can the immune effect of the BNT162b2 vaccine last? Will you consider a third shot to boost immunity and efficacy as some other producers have? Are relevant studies and trials ongoing?

Sahin: The antibody response after vaccination declines over time. This is normal for all types of vaccines. We now have 6 months of efficacy data from our global trials. After six months, the vaccine still has 91 percent of efficacy. So this is still high. However, we saw that there is a decline in antibodies after 8 months. So it is a good idea to consider booster shots with not only our own vaccine but also other types. We are considering to evaluate the combination of our vaccine with vector-based vaccines and inactivated ones as potential booster shots to stabilize the antibody level against the coronavirus disease once the immune response of antibodies wanes. 

GT: Reports have revealed multiple cases in the US of the vaccines' improper temperature storage degrading their quality. Are you making some efforts toward improving the accessibility of the BNT162b2 in terms of temperature?

Sahin: We have already increased the duration for the range of 2 to 8 degrees. We will come up with updated data showing that our vaccine can be stored for a longer time at - 20 or 2 to 8C. We will continue to leverage our expertise to develop potential new formulations that can be stored at 2 to 8C for at least 3 months. These potential formulations could become available in autumn.

Prospect of approval in mainland

GT: The Wall Street Journal on April 16 reported that the BioNTech-Fosun vaccine is expected to be approved in the mainland within about 10 weeks. What are the prospects of BNT162b2 being widely used in the Chinese mainland?

Sahin: We have been in touch with the Chinese authorities since we started our cooperation with Fosun Pharma. The Chinese authorities are extremely diligent. Now we are in the final process, and the conversation with the authorities is encouraging. 

We are confident about the final decision of the authorities based on the benefits that our vaccine could bring for China and for the elderly people. We are optimistic about it being approved soon.

GT: It is interesting that we notice in the conversation between you and the Shanghai municipal government you even give yourself a Chinese name which is really impressive to the Chinese public. Should we believe that it is a kind of signal to deliver your confidence to the Chinese market?

Sahin: Yes, my confidence is really based on the great international collaboration that happened between different governments. I'm from Turkey. 

I know that the Chinese vaccines have also been delivered to Turkey and are helping Turkish people. 

If we can work together and make our vaccine available in China, we would be happy to engage ourselves as much as possible.

GT: How did the cooperation start? Why did you choose Shanghai-based Fosun as a co-developing partner?

Sahin: I met with Dr. Aimin Hui, President of Global R&D and Chief Medical Officer of Fosun Pharma in early February 2020. At that time, the outbreak was still ongoing in China. Instead of engaging in business discussions, we just started to develop a clinical trial plan during a dinner.

We just took pieces of paper and started to design a clinical pipeline, because we knew there's no time to lose, and we need to come up with specific scenarios as soon as possible. 

We realize how we are diligent and how we can be driven by the desire to do something. We speak the same language and that is the foundation of our working together. For me, it was clear that Fosun has the same motivation, the same standard, and the same deep scientific understanding as we do. It is the feeling of trust from the very beginning.

GT: Why did BioNTech determine to use mRNA technology to design the COVID-19 vaccine at the very beginning? 

Sahin: We have been developing our mRNA technology for more than 20 years - even before founding BioNTech.  Thus, messenger RNA is our expertise. The mRNA technology is based on a beautiful concept: Instead of making a vaccine outside of the human body, mRNA vaccines provide a piece of genetic information taken up by human cells to activate the body's immune response. mRNA is a natural molecule. Vaccines based on this molecule utilize the genetic sequencing of the virus but not the virus itself. 

We spent more than 10 years optimizing our technology at BioNTech. We have always been driven by our mission to improve the health of people around the world. When COVID-19 arose, we saw it as our duty to use our decades of research expertise to make an important contribution to getting this global pandemic under control.

GT: What do you think the success of this mRNA vaccine means for the future development of this technology?

Sahin: Before COVID-19, there was no approved mRNA vaccine. But today we have delivered more than 350 million doses of vaccines worldwide, and we have various data demonstrating the high efficacy and favorable safety and tolerability profile of our vaccine. So this new drug class could now become a new industry standard because of advantages such as short manufacturing timelines, the development speed, and because it lacks any animal material. It is a clean technology with a lot of advantages.  

Other technologies will continue to remain with excellent vaccine technologies. In addition, we have a new technology which could support and could be positioned in a complementary way, for example, in eliciting strong immune responses in elderly people.