-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Just days after expressing hope of obtaining key data from the Phase III clinical trial of the COVID-19 vaccine in October, BioNTech, a German biotech company, received a grant of up to 375 million euros from the German Federal Ministry of Education and Research (BMBF) to support the accelerated development of its COVID-19 vaccine.
BioNTech hopes to use the money to support its mRNA BNT162 vaccine program, developed in partnership with Pfizer.
BMBF's real money is supported by plans to expand vaccine development and production capacity in Germany and expand participation in late-stage clinical trials.
the company plans to use grants to pay for its development plans, Pfizer will continue to fund some of its development costs independently without the need for this or other government funds.
the grant is milestone-based, the funding is based on a preclinical evaluation of candidate vaccines, including the initiating and implementation of phase I and II/III clinical trials of four clinical development milestones.
includes increased production capacity for clinical trials and targeting the general population, if approved, as well as several milestones submitted to regulators and future markets.
, BioNTech has reached five of the eight defined milestones.
, BioNTech received approval from Paul-Ehrlich-Institut, a German regulator, to conduct a Phase II/III vaccine study in Germany on the new crown candidate vaccine BNT162b.
that recruitment has begun on three continents, with more than 28,000 participants already enrolled in the United States, Brazil, Argentina and Europe.
September 12, BioNTech and Pfizer announced plans to expand phase III vaccine trials from the planned 30,000 volunteers to a maximum of about 44,000 participants.
the reason for the expansion is to increase the diversity of trials to include adolescents under the age of 16 and people with chronic, stable HIV, hepatitis C and B, and to collect more safety and importance data.
is expected to reach the 30,000 mark next week.
Uur Sahin told CNN last week that our vaccine "has excellent characteristics, and I think the vaccine... Close to perfection and characterized by near perfection."
said he believed regulators would quickly approve or approve "emergency use authorizations" and said they were "confident" in their "understanding of how they work and the safety data from ongoing trials".
..." We believe we have safe products and we believe we will be able to demonstrate their effectiveness.
, however, Pfizer Inc said on Wednesday that volunteers using the company's new crown vaccine or placebo had mild to moderate side effects in an ongoing late-stage clinical study of the new corona vaccine.
the company says side effects include fatigue, headaches, chills and muscle pain.
volunteers in the trial also developed fever symptoms, including a high fever.
it is worth noting that the new crown vaccine for adenovirus vectors in Oxford and AstraZeneta has been recovered after it was revealed that a clinical trial participant in the UK had developed a suspected serious adverse reaction and briefly suspended Phase III clinical trials.
in our trials, fever symptoms were not common," said Uur Sahin, a professor of fever.
, only a small percentage of the participants in the trial had a fever.
we also see much lower symptoms such as headaches or tiredness.
the vaccine is temporary and usually disappears after one or two days of observation.
reportedly recruited 44,000 volunteers for the new crown vaccine, developed jointly with German vaccine maker BioNtech, and 29,000 people have taken part in the trial.
, Pfizer executives said on an investor conference call that more than 12,000 volunteers had been given a second dose of the vaccine.
comes after Pfizer and BioNTech reached a supply agreement with the European Union to supply 200 million doses of the vaccine to EU member states, as well as an additional 100 million doses, with delivery scheduled to begin by the end of 2020.
, of course, depends on the results of clinical trials and regulatory approval of the vaccine.