What Is the BioNTech-Pfizer Vaccine Developed by Uğur Şahin and Özlem Türeci, and How Does It Work?

Scientists and the public worldwide warmly welcomed COVID-19being preventable with a vaccine — the first convincing evidence. However, questions remain about how long protection lasts, whom it protects, and to what extent.

Two Turkish scientists conducting research in Germany, Uğur Şahin and his wife Özlem Türeci, made history in science and humanity with the first vaccine they developed at BioNTech against the novel coronavirus (SARS-CoV-2), shown in interim results on November 9 to be 90% effective. This development brought great excitement to the world and great pride to us.

Major development 1: The BioNTech vaccine has arrived in Turkey

According to the Turkish Ministry of Health’s March 31, 2021 statement, the BionTech vaccine has joined the coronavirus vaccination program in Turkey. Following the latest shipments, a total of 2.8 million doses were placed in the Ministry’s public health warehouses with special storage conditions. After analysis, administration will begin, with doses reaching 4.5 million in April. An optional agreement was also reached with the company for 30 million doses. Efforts to bring the vaccine to Turkey will continue as the company’s production capacity increases

Major development 2: The BioNTech vaccine provides protection for at least 6 months after the second dose

According to the April 1, 2021 statement by Pfizer and BioNTech, their mRNA COVID-19 vaccines provide protection for at least 6 months after the second dose.

An analysis of 927 symptomatic cases through March 13 showed that the vaccine was 91.3% effective against COVID-19, as demonstrated by real-world data compiled since emergency use authorization. This is similar to the 95% efficacy reported in interim results announced on November 18, 2020.

Data released today also show that the vaccine provides 100% protection against severe COVID-19 as defined by the US Centers for Disease Control and Prevention.

The vaccine’s effectiveness was also similar in South Africa, where the B.1.351 variant of concern was first identified, including effectiveness in preventing COVID-19.

FDA grants Emergency Use Authorization to Pfizer/BioNTech’s BNT162b2 vaccine

On December 11, 2020, the US Food and Drug Administration (FDA) granted emergency use authorization to the BioNTech vaccine. This is not final approval, but it is the first coronavirus vaccine authorization for widespread use in the USA.

Under the FDA decision, the vaccine can be given to people over age 16.

The first phase of vaccination in the USA is expected to use 2.9 million doses, primarily for healthcare workers and older residents of care homes.

BioNTech CEO Prof. Dr. Uğur Şahin said, "It is very important that authorization has been granted now."

Britain was the first to authorize use of the Pfizer/BioNTech vaccine in early December. Vaccination has begun in the United Kingdom. Canada, another country authorizing the vaccine, will begin vaccination next week. 

Bahrain and Mexico have also authorized use of the Pfizer/BioNTech vaccine.

On December 10, NEJM published the final results of this vaccine’s phase-III study, summarized below:

Manage preferences to view external content

Manage preferences to view external content

Who are Uğur Şahin and Özlem Türeci? Brief biographies

Dr. Uğur Şahin is an immunologist and physician in Germany. He is a professor of oncology at Mainz University and the managing director and cofounder of the biotechnology company BioNTech. Dr. Özlem Türeci is a prominent scientist who has conducted cancer research for more than 20 years. She has developed new techniques to train the immune system against cancer cells.

BioNTech was founded in 2008 by Özlem Türeci and Uğur Şahin, whose families migrated from Turkey to Germany. Born in İskenderun, Uğur Şahin moved to Germany with his family at age four. His father worked for many years at the Ford factory in Cologne.

Özlem Türeci’s father was a doctor in Istanbul. Her family migrated to Germany before she was born. Türeci met her husband while working in Hamburg. Türeci says, "Even on our wedding day, we worked in the laboratory".

Uğur Şahin and his wife are now among Germany’s 100 wealthiest people. According to Britain’s Telegraph newspaper, the couple sold their first company, Ganymed, for 1.4 billion euros. BioNTech’s market value has exceeded 20 billion euros.

The BioNTech–Pfizer partnership

With the coronavirus pandemic in 2020, the company reached an agreement with a leading international pharmaceutical company, Prifzer, to develop a SARS-Cov-2 vaccine. The European Union signed a contract for 200 million doses from the companies’ joint venture. If the vaccine succeeded, Japan had contracted for 120 million doses, the USA for 100 million, and the United Kingdom for 30 million. The company’s market value, now exceeding 20 billion euros, is greater than Prosche’s and Deutsche Bank’s, according to The Times. The Wall Street Journal reports that the company has tripled in value since January. Using the mRNA method, which enables faster and larger-scale production than conventional vaccine methods, the company aims to have produced more than 100 million doses by year’s end. Other cofounders include German billionaire brothers Thomas and Andreas Struengmann, who were also partners in Türeci and Şahin’s Ganymed company. According to Euronews, BioNTech formed two research groups working seven days a week since January, at Şahin’s urging, to obtain faster results. Şahin named the effort the "Speed of Light Project" (Project Lightspeed). Because travel to the USA was prohibited at the time, some genetic materials developed in the laboratories were flown there on a private jet belonging to Pfizer executives. Euronews reports that BioNTech will own the vaccine, while Pfizer will receive certain privileges under the partnership. Under the agreement between BioNTech, with 1,500 employees, and Pfizer, with more than 100 thousand, BioNTech opened its mRNA research to Pfizer, which had closed its infectious diseases unit several years earlier, the Wall Street Journal reports.

How does the BioNTech / Pfizer vaccine work?

The vaccine developed under the leadership of Uğur Şahin and Özlem Türeci is a type of nucleic acid vaccine(see types of vaccines developed against coronavirus). There are 2 types of nucleic acid: DNA and RNA. At the German company BioNTech, Turkish scientists developed an RNA vaccine against coronavirus. The vaccine encodes the SARS-CoV-2 surface protein using messenger RNA (mRNA). The mRNA is covered with a nanoparticle lipid layer, allowing it to enter cells. The mRNA prepared as a vaccine can replicate itself within cells and is translated inside them to produce SARS-CoV-2 surface (spike) proteins. The mRNA particle attaches to a ribosome inside the cell and enables production of viral proteins, introducing viral molecules to our immune system.

Unlike conventional vaccines using inactivated virus or protein, mRNA vaccines use only the virus’s genetic material. They therefore have a very high safety profile (few side effects). The mRNA technology was originally developed specifically for cancer treatments. mRNA vaccines are also being tested against viral infections such as influenza, cytomegalovirus, HIV (the cause of AIDS), measles, Zika, and Ebola.

The BioNTech / Pfizer vaccine: advantages and unknowns

It works! Scientists greeted a press release announcing positive interim results from this coronavirus vaccine trial with cautious optimism.

Pfizer’s November 9 announcement that a vaccine can prevent COVID-19 provided the first convincing evidence — and is a good sign for other COVID-19 vaccines in development. However, information released at this early stage does not answer key questions about whether Pfizer’s vaccine and similar vaccines can prevent the most severe cases or bring the coronavirus outbreak under control.

Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York and one of more than 40 thousand trial participants, said, “Ultimately, we need to see the data, but that does not diminish our excitement. This is wonderful.” He added, “I hope I am not in the placebo group.”

The vaccine contains molecular instructions in mRNA form for human cells to make coronavirus spike proteins. This prepares the body’s adaptive immune system to respond to the spike proteins produced by human cells. The Pfizer vaccine, administered in two doses, has shown promise in animal studies and early clinical trials. But the only way to know whether it works is to give it to many people and monitor them for weeks or months for infection and symptoms. The results are compared with a group given a placebo.

Interim results

Pfizer and BioNtech announced in a press release that, among 43,538 participants, they had identified 94 COVID-19 cases. The companies did not say how many were in the placebo or vaccinated groups. Measurements at least a week after the second dose showed the vaccine to be more than 90% effective at preventing disease (the second dose was given 3 weeks after the first). The trial will continue until 164 COVID-19 cases are identified, so initial estimates of efficacy may change.

A cardiologist and director at the Scripps Research Translational Institute in La Jolla, California, known worldwide for his active use of social media, Dr. Eric Topol “Even if the vaccine proves less effective when the trial is completed and all data are analyzed, it is quite likely that efficacy will remain above 50%”, says Topol. This is the threshold required for the US Food and Drug Administration (FDA) to grant emergency use authorization to a coronavirus vaccine. Topol continues, “Even without many details, I think this is an extraordinary achievement because, before the first trial results, there was no assurance that the vaccine would be effective”.

Some remaining questions

Topol and other scientists say the missing details concern the nature of the infection against which the vaccine protects. COVID-19 varies in severity: usually mild or asymptomatic, and less often moderate or severe. Paul Offit, a vaccine scientist at the University of Pennsylvania who sits on the FDA advisory committee evaluating the vaccine next month, says, “I want to know the range of disease that the vaccine prevents”. How well it prevents severe COVID-19 cases will become clear over time.

It is also uncertain whether the vaccine prevents coronavirus transmission by people with no or very mild COVID-19 symptoms. A vaccine that blocks transmission could hasten the pandemic’s end. But Krammer says it is difficult to tell whether Pfizer’s vaccine or other late-stage trials can achieve this because participants are routinely tested. “You cannot do that with 45 thousand people”, he says.

Another missing detail is how well it works across different participant groups. Krammer says, “among those who need it most, the older population, we do not yet know whether it works”. Offit says the small number of cases emerging before completion makes it unlikely that the Pfizer trial can precisely determine efficacy in subgroups such as those over 65 or African Americans. He adds, “But enrolling enough participants from these groups may allow potential efficacy in them to be developed”. Pfizer and BioNTech reported that 42% of participants had racially and ethnically diverse backgrounds.

Lasting immunity?

One key unanswered question is how long the vaccine’s efficacy will last. Rafi Ahmed, an immunologist at Emory University in Atlanta, Georgia, says previously published immune-response data from early trials, together with when the trial began, suggest that many participants probably still have high levels of protective antibodies in their blood. “For me, the real question is what happens after six, or even after three months?”, he says.

Ahmed says continuing the trial for a few more months would provide a chance to answer this. Answers might also come from analyzing immune responses in people in early Pfizer trials who may have been vaccinated up to six months ago. Although little is known about long-term efficacy, he says its use is unlikely to be delayed. “I do not think we should say that I will take a vaccine only if it protects me for five years. That could be crazy.”

The results support other teams developing COVID-19 vaccines. Krammer says these include a vaccine developed by Cambridge, Massachusetts biotechnology company Moderna and the US National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, which also consists of mRNA. “I expect Moderna shares to rise today.”

Vaccine immunologist Shane Crotty of the La Jolla Institute for Immunology in California thinks Moderna is not the only developer that should celebrate Pfizer’s early results. Several other candidates triggered immune responses in early trials similar to those produced by Pfizer’s vaccines, so they too should work well.

One thing is certain about the Pfizer vaccine: regulators will soon assess whether it is ready for market release. The company said it would request FDA emergency use authorization around the third week of November, when participants would have an average follow-up of around 2 months — an FDA safety requirement for COVID-19 vaccines.

Although researchers want to see the data behind Pfizer’s trial, they are also prepared to accept its caveats. Krammer says, “We need a vaccine that works right now”, even if it works for only a few months or does not stop transmission. “That is what we need to return to normal.”

Over the next 2-3 weeks, at least 2 more companies may announce vaccine results: Moderna and the AstraZeneca-Oxford partnership. If they also bring positive news, there will be 3 vaccines with a high likelihood of approval. By January-February, this could reach 5-6. We can look toward spring and summer with greater hope regarding the pandemic.

Prof. Dr. Uğur Şahin: "We want to reserve enough vaccine for Turkey"

On November 10, Uğur Şahin said, "We will also need to hold discussions with the Ministry of Health for Turkey. If a protocol is signed, it will become possible to bring vaccine doses to Turkey in January-February-March. If the Ministry tells us how many doses are needed and when, we want to reserve enough vaccine for Turkey."

*

RELATED TOPICS

• Covid-19 current statistics for the world and Turkey
• Breaking news and scientific developments about coronavirus

*

FURTHER READING

New-generation mRNA vaccines must be stored and transported at much lower temperatures

Company statements and preparations have shown that mRNA vaccines must be stored and transported at a lower temperature: -70 degrees Celsius. It was also stated that they must be used within 5 days after transportation in this way. BioNTech’s production centers are in Germany, Belgium, and the USA.

The graphic below shows vaccine storage and transport conditions:

Pfizer built a large facility in the US state of Michigan. Its target is 1.3 billion doses next year and 100 million by year’s end. It is also producing specially designed containers holding 5000 doses for the cold chain.

Which countries invested most in coronavirus vaccines?

The graphic below shows countries’ agreements with vaccine manufacturers. The United Kingdom has preordered more than 5 doses per citizen across 6 leading vaccine candidates. It is followed by the USA, Canada, Japan, and Europe.

The charity Oxfam stated that these wealthy countries’ combined agreements with vaccine manufacturers represent only 13% of the world’s population, while securing more than half of the promised doses.

Covax, a global vaccine procurement partnership designed to ensure equitable dose distribution, was established with 64 participating countries. We hope this joint effort for equal and fair distribution succeeds.