World: Pfizer and BioNTech propose to expand COVID-19 vaccine trial to 4

Pfizer Inc and BioNTech SE proposed on Saturday to the U.S. Food and Drug Administration (FDA) to expand Phase III of its COVID-19 vaccine candidate to about 44,000 participants while increasing the diversity of the population involved in the study.

The initial target number for the test was up to 30,000 participants, which the companies said they hope to hit next week.

The proposed expansion would also allow companies to enroll people up to 16 years old and people with chronic stable HIV, hepatitis C and hepatitis B, they added.

Drug makers rushing to develop a Safe and Effective pledged in July to ensure that their larger clinical trials would include diverse groups of volunteers.

“Diversity in clinical trials is a priority for and it is fundamental since the COVID-19 disproportionately impacts communities of color in the United States, ”said the business director of PfizerJohn Young at a US Congressional hearing in July.

If the study is successful, companies could submit the vaccine for your starting in October, putting them on track to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.

“As indicated above, based on current infection rates, companies continue to hope that a conclusive reading on efficacy is likely to be obtained by the end of October,” the companies added in the joint statement Saturday.

The vaccine candidate uses chemical messenger RNA to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. Although the technology has been around for years, there has never been an approved messenger RNA (mRNA) vaccine.

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EU orders millions of vaccine doses from Biontech

Dhe biotechnology company Biontech from Mainz, together with the American pharmaceutical giant Pfizer, has concluded a potential agreement with the European Commission for the delivery of vaccine doses against the coronavirus. In the event of clinical success in research on a vaccine and regulatory approval, 200 million doses should be sent to member states of the European Union to be delivered. The EU Commission can purchase a further 100 million cans.

The planned agreement is the largest initial order for the delivery of a vaccine for the Mainz-based company to date. The vaccination doses for Europe should be in production facilities in Germany (Biontech) and Belgium (Pfizer) getting produced. If the vaccine candidate named BNT162b2 is approved, the Commission will distribute the doses to the 27 member states of the EU, according to a statement from Biontech on Wednesday.

“The proposed agreement between Pfizer and Biontech with the European Commission is another important step in our shared goal of making millions of doses of a vaccine against Covid-19 available to vulnerable populations before the end of the year,” said Albert Bourla, Chairman and CEO from Pfizer.

Largest order for the vaccine to date

“As a company that was founded in the heart of Europe, we are very pleased about the conclusion of the first talks with the European Commission on our largest initial order to date,” said Ugur Sahin, CEO and co-founder of Biontech. His company aims to be safe and effective vaccine to develop that could help counter this pandemic in Europe and around the world. “Today’s decision is another example of how collaboration and solidarity can help address a global health crisis as an international community,” said Sahin.

Ugur Sahin is co-founder and CEO of Biontech.


Ugur Sahin is co-founder and CEO of Biontech.
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Image: dpa


The BNT162 program is based on Biontechs Messenger RNA (mRNA) technology, which is a template for the production of proteins in cells, and is supported by Pfizer’s expertise in global vaccine development and production. Two of the four vaccine candidates in clinical development – BNT162b1 and BNT162b2 – received FDA fast-track status.

Test on 30,000 subjects

In the advanced clinical trial, the companies are testing the vaccine on up to 30,000 subjects between the ages of 18 and 85 years. So far, more than 25,000 test subjects have been recruited for the phase 2/3 study. The subjects are currently being immunized for the second time.

If the clinical trials are successful, Pfizer and Biontech plan to apply for regulatory approval for the active ingredient as early as October 2020 and, should approval or approval, up to 100 million vaccine doses by the end of 2020 and over 1.3 billion doses by the end of 2021 to manufacture. In order to meet the planned volumes, the two companies have already started producing and storing vaccine doses for the fight against the pandemic.

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EU orders millions of vaccine doses from Biontech

Dhe biotechnology company Biontech from Mainz, together with the American pharmaceutical giant Pfizer, has concluded a potential agreement with the European Commission for the delivery of vaccine doses against the coronavirus. In the event of clinical success in research on a vaccine and regulatory approval, 200 million doses should be sent to member states of the European Union to be delivered. The EU Commission can purchase an additional 100 million cans.

The planned agreement is the largest initial order for the delivery of a vaccine for the Mainz-based company to date. The vaccination doses for Europe should be in production facilities in Germany (Biontech) and Belgium (Pfizer) getting produced. If the vaccine candidate named BNT162b2 is approved, the Commission will distribute the doses to the 27 member states of the EU, according to a statement from Biontech on Wednesday.

“The proposed agreement between Pfizer and Biontech with the European Commission is another important step in our common goal of making millions of doses of a vaccine against Covid-19 available to vulnerable populations before the end of the year,” said Albert Bourla, Chairman and CEO from Pfizer.

Largest order for the vaccine to date

“As a company that was founded in the heart of Europe, we are very pleased about the conclusion of the first talks with the European Commission on our largest first order to date,” said Ugur Sahin, CEO and co-founder of Biontech. His company aims to be safe and effective vaccine to develop that could help counter this pandemic in Europe and around the world. “Today’s decision is another example of how collaboration and solidarity can help address a global health crisis as an international community,” said Sahin.

Ugur Sahin is co-founder and CEO of Biontech.


Ugur Sahin is co-founder and CEO of Biontech.
:


Image: dpa


The BNT162 program is based on Biontechs Messenger RNA (mRNA) technology, which is a template for the production of proteins in cells, and is supported by Pfizer’s expertise in global vaccine development and production. Two of the four vaccine candidates in clinical development – BNT162b1 and BNT162b2 – received FDA Fast-Track status.

Test on 30,000 subjects

In the advanced clinical trial, the companies are testing the vaccine on up to 30,000 subjects between the ages of 18 and 85 years. So far, more than 25,000 test persons have been recruited for the phase 2/3 study. The subjects are currently being immunized for the second time.

If the clinical trials are successful, Pfizer and Biontech plan to apply for regulatory approval for the active ingredient as early as October 2020 and, should approval or approval be granted, up to 100 million vaccine doses by the end of 2020 and over 1.3 billion doses by the end of 2021 to manufacture. In order to meet the planned volumes, the two companies have already started producing and storing vaccine doses for the fight against the pandemic.

.

EU orders millions of vaccine doses from Biontech

Dhe biotechnology company Biontech from Mainz, together with the American pharmaceutical giant Pfizer, has concluded a potential agreement with the European Commission for the delivery of vaccine doses against the coronavirus. In the event of clinical success in research on a vaccine and regulatory approval, 200 million doses should be sent to member states of the European Union to be delivered. The EU Commission can purchase an additional 100 million cans.

The planned agreement is the largest initial order for the delivery of a vaccine for the Mainz-based company to date. The vaccination doses for Europe should be in production facilities in Germany (Biontech) and Belgium (Pfizer) getting produced. If the vaccine candidate named BNT162b2 is approved, the Commission will distribute the doses to the 27 member states of the EU, according to a statement from Biontech on Wednesday.

“The proposed agreement between Pfizer and Biontech with the European Commission is another important step in our common goal of making millions of doses of a vaccine against Covid-19 available to vulnerable populations before the end of the year,” said Albert Bourla, Chairman and CEO from Pfizer.

Largest order for the vaccine to date

“As a company that was founded in the heart of Europe, we are very pleased about the conclusion of the first talks with the European Commission on our largest first order to date,” said Ugur Sahin, CEO and co-founder of Biontech. His company aims to be safe and effective vaccine to develop that could help counter this pandemic in Europe and around the world. “Today’s decision is another example of how collaboration and solidarity can help address a global health crisis as an international community,” said Sahin.

Ugur Sahin is co-founder and CEO of Biontech.


Ugur Sahin is co-founder and CEO of Biontech.
:


Image: dpa


The BNT162 program is based on Biontechs Messenger RNA (mRNA) technology, which is a template for the production of proteins in cells, and is supported by Pfizer’s expertise in global vaccine development and production. Two of the four vaccine candidates in clinical development – BNT162b1 and BNT162b2 – received FDA Fast-Track status.

Test on 30,000 subjects

In the advanced clinical trial, the companies are testing the vaccine on up to 30,000 subjects between the ages of 18 and 85 years. So far, more than 25,000 test persons have been recruited for the phase 2/3 study. The subjects are currently being immunized for the second time.

If the clinical trials are successful, Pfizer and Biontech plan to apply for regulatory approval for the active ingredient as early as October 2020 and, should approval or approval be granted, up to 100 million vaccine doses by the end of 2020 and over 1.3 billion doses by the end of 2021 to manufacture. In order to meet the planned volumes, the two companies have already started producing and storing vaccine doses for the fight against the pandemic.

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Coronavirus: Biontech and Pfizer expect to commercialize the vaccine in October

The laboratories will carry out the first tests in Germany and will also carry out a worldwide test, where Argentina was included.

The German biopharmaceutical company Biontech and his American partner Pfizer will test your vaccine against coronavirus in Germany.

Both companies will do the tests after receive permission from the official German agency and intend to start marketing in October if the results are positive.

“A large, controlled phase III study is an essential prerequisite to demonstrate beyond doubt the safety and efficacy of a vaccine,” said Ugur Sahin, CEO of Biontech, the agency said. DPA.

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“The participation of study centers in Europe, and now also in Germany, have the specific objective of supporting a local approval,” he added.

If the current clinical study on your vaccine coronavirus is successful, Biontech and Pfizer intend to request the marketing authorization in October, they specified from the laboratories.

TESTS IN ARGENTINA

At the end of July, a worldwide study on the possible vaccine began with 30,000 participants, including Argentina, which, led by researcher Fernando Polack, tests thousands of volunteers in the Military Hospital of Buenos Aires.

The active substance chosen for the phase II / III clinical study was BNT162b2 and the aim of the study is to test the efficacy of the vaccine and determine the appropriate dose.

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Pfizer and BionTech, US vaccine for Covid-19 arriving in October

U.S. pharmaceutical company Pfizer and Germany’s BioNTech said they were on track to apply for regulatory approval of their BNT162b2gi Covid vaccine next October. Pfizer explained in a statement that if authorization or regulatory approval is obtained, they plan to supply up to 100 million doses worldwide by the end of 2020 and about 1.3 billion doses by the end of 2021.

Phase 2

The two companies have initiated Phase 2 of 3 of the vaccine testing globally to evaluate its effectiveness. In the first phase (at the second dose in progress) 11,000 people between the USA and Germany were involved and the results are encouraging: the vaccine was well tolerated. In the second, 30,000 people aged between 18 and 85 are expected to participate in the United States, Argentina, Brazil, Germany, Turkey and South Africa.
Aiming to launch the vaccine in October, US futures took a leap overnight. The time line of the two companies would make the vaccine one of the fastest in the world. Some analysts expect it to be approved in the United States as early as November in order to be able to enter the market immediately, a move that could work in favor of the current President Trump for the next elections.

The aziede

Pfizer was born in 1849, in New York, by two German immigrants, cousins ​​Charles Pfizer and Charles Erhart who began to produce raw materials for the chemical and food sector obtained thanks to fermentation processes. He subsequently became a producer of tartaric acid, citric acid, vitamin C and was able to mass produce penicillin of which he became a global producer. After more than 150 years of history, it develops, produces and markets vaccines and drugs, for the treatment and prevention of diseases, both the most common and the rare ones.
BioNTech a German biotechnology company dedicated to the development and production of active immunotherapies. Founded in 2008, it combines innovative research with cutting-edge technologies to develop pioneering therapies for cancer and more.

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Vaccination against Corona: The fear of the cytokine storm after vaccination

Shibo Jiang, a virologist with chairs in the US and China, is worried about the pace of the search for a vaccine. Jiang already warned in March in the trade magazine “Nature”Before“ quick fix ”programs:“ Don’t get me wrong. Working on a vaccine as quickly as possible now is crucial. But it is also important not to take any abbreviations. “

Jiang is one of the researchers who began looking for a vaccine back in 2003, in the middle of the first global Sars outbreak in southern China. He hasn’t stopped since then, as the vaccines have been either ineffective or too dangerous.

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Coronavirus vaccine trials began in the country – News

The tests of the vaccine against Covid-19 began in Argentina with the applications to the first volunteers.

The study is carried out at the Central Military Hospital of the City of Buenos Aires by a work team that includes more than 500 professionals, and is led by Dr. Fernando Polack, Dr. Gonzalo Pérez Marc and Dr. Romina Libster.

Of the more than 20,000 registered volunteers from the AMBA region, approximately 4,500 are being selected to participate in the same.

To be a volunteer in this phase of the clinical study of the vaccine, people must be between 18 and 85 years old, in addition to not having been infected with the coronavirus.

Half of the participants will receive the vaccine in development and half a placebo, in a study design called “double blind”, in which neither the treating physicians nor the volunteers know the content of the administered product.

This will ensure the complete objectivity of the results that will be obtained in order to demonstrate the efficacy of the vaccine under development.

All participants will receive a second dose after 21 days, and will remain under strict clinical control for at least two years. However, the first preliminary results are expected in a few months, which will allow the efficacy of the vaccine to be evaluated by the regulatory authorities.

The study of this vaccine, called BNT162b2 and developed by Pfizer and BioNTech, has already successfully gone through phases 1 and 2 of the trial in the US and Germany, and will include a total of 30,000 volunteers globally in more than 120 institutions in at least 3 countries in its phase 3: USA, Argentina and Brazil.

The research sites were selected based on their experience in this type of study and their logistical capacity to adapt to the demands of research during the pandemic.

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Sahin and Türeci are developing a vaccine

Mainz Ugur Sahin and Özlem Türeci do not currently have much time for their private lives. The focus of the two doctors is their company. Your mission: the fight against Covid-19.

That seems to be paying off: the stock listed on the US technology exchange Nasdaq gained almost 50 percent overnight. With currently around $ 12 billion, Biontech is worth almost three times as much as the one stumbling in the pandemic Lufthansa.

Together with the US pharmaceutical company Pfizer and the Chinese company Fosun, both of which have a minor stake in Biontech, are now expected to break through in the corona crisis.

Mainz has been researching an influenza vaccine with Pfizer for a long time. Nevertheless, vaccines against infectious diseases have so far been a minor issue. The company that Sahin founded in 2008 with the immunologist Christoph Huber specializes in individualized cancer therapies. The goal: to activate defense reactions against tumors in cells.

The pandemic shows: Sahin and Türeci are not bogged down in technology. When they first heard about the virus, they were convinced that they could contribute to the fight against Covid-19. 400 of the 1300 employees are now working around the clock on vaccine development, in three shifts, as the “Manager Magazin” wrote.

Biontech expects interim results at the end of June. If the first study is successful, a larger test run could begin in autumn. But Sahin curbs the euphoria: he does not believe that the vaccine will be approved before 2021. Nevertheless, that would be a record pace: New vaccine developments would otherwise take decades. It is not without reason that the project bears the name “Lightspeed”.

Scientist at heart

Despite his leading role, Sahin sees himself primarily as a scientist and continues to teach as a professor of experimental oncology at Mainz University. “We are a technology company, not a classic pharmaceutical company,” he once said. “Our success depends on what we do technologically and medically work.”

Sahin who liked his company with the electric car maker Tesla compares, is viewed in the oncologist community and received the “German Cancer Award” in 2019 for its research. Sahin comes from southern Turkey and received her doctorate in Cologne in 1990. Türeci’s family comes from Istanbul, the father worked as a country doctor in Lower Saxony. The two met in Saarland, at the University of Homburg.

Türeci founded her first company with other partners in 2001: Ganymed Pharmaceuticals. In 2016, the Japanese pharmaceutical company Astellas bought the company for 422 million euros – the largest deal to date in the still young German biotech industry. Ganymed developed antibodies for targeted cancer therapies.

Biontech also includes the Hexal founders and investors Andreas and Thomas Strüngmann. Your family office owns half of the shares. Bill Gates also invested. Sahin himself holds a good fifth of the shares. This makes him the second largest shareholder after Strüngmanns. On paper, Sahin is now worth more than two billion euros.

That shouldn’t mean much to him. “Sahin has never put monetization in the foreground,” said Thomas Strüngmann in an interview with Handelsblatt last year. “His dream coincides with ours to build something sustainable, permanent and to develop fundamentally new, better therapies.” Sahin and Türeci are “exceptional phenomena” with what scientific foundations they have created for the company – “and with what passion push it forward ”.

More: New technologies are stirring up the vaccine market

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Corona Vaccine Study: The Hope of Hope Biontech

Dhis name sounds like a prophecy. “Lightspeed”, the speed of light, is the name of the project with which Ugur Sahin and his company Biontech want to achieve nothing less than to rid the world of the danger of the corona virus. The Mainz-based company and its founder and CEO announced on Wednesday that the Paul Ehrlich Institute in Langen had approved the clinical study for Biontech’s vaccine program called BNT162 for the prevention of Covid-19 infection. So it’s official: Biontech is one of the hopes in the fight against the pandemic and is now allowed to test its means – a so-called RNA vaccine – on around 200 healthy volunteers to test the substance for tolerability and effectiveness.

Daniel Schleidt

The news is another milestone in the relatively young history of a company that has been causing a stir with hopeful research results, bold goals and strong growth for years. The development and testing of the approved vaccine candidate was carried out at an impressive rate: the Biontech scientists only started to develop a concept in mid-January, and research began shortly afterwards. Now it goes into the test phase, and that leaves room for dreams: One is that there could soon be a vaccine against Covid-19 – and that this could come from the Rhineland-Palatinate capital.

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