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News on May 30, 2021 /bioon.
com" target="_blank">/ --At present, the epidemic situation of new crown pneumonia abroad is still spreading rapidly.
According to Baidu's "New Coronavirus Pneumonia Epidemic Real-time bioon.
com/tags/%E5%A4%A7%E6%95%B0%E6%8D%AE/" target="_blank">Big Data Report", as of 19:00 on May 30, 2021, more than 170 million (170.
68 million) cases have been diagnosed globally and more than 3.
549 million deaths have been diagnosed worldwide .
bioon.com" target="_blank">/ --At present, the epidemic situation of new crown pneumonia abroad is still spreading rapidly.
According to Baidu's "New Coronavirus Pneumonia Epidemic Real-time bioon.
com/tags/%E5%A4%A7%E6%95%B0%E6%8D%AE/" target="_blank">Big Data Report", as of 19:00 on May 30, 2021, more than 170 million (170.
68 million) cases have been diagnosed globally and more than 3.
549 million deaths have been diagnosed worldwide .
com" target="_blank">bioon.
com/tags/%E5%A4%A7%E6%95%B0%E6%8D%AE/" target="_blank">170 million (170.
68 million) cases of bioon.
com/tags/%E5%A4%A7%E6%95%B0%E6%8D%AE/" target="_blank">big data
Recently, bioon.
com/tags/%E8%BE%89%E7%91%9E/">Pfizer and its partner BioNTech jointly announced that the conditional marketing authorization (CMA) of its COVID-19 mRNA vaccine Comirnaty (BNT162b2) in the EU has been extended to include 12-15 year olds .
Prior to this, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive review suggesting that Comirnaty should be approved for use in this age group.
The expansion of Comirnaty CMA indications is valid in all 27 member states of the European Union.
bioon.com/tags/%E8%BE%89%E7%91%9E/">Pfizer and its partner BioNTech jointly announced that the conditional marketing authorization (CMA) of its COVID-19 mRNA vaccine Comirnaty (BNT162b2) in the EU has been extended to include 12-15 year olds .
Prior to this, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive review suggesting that Comirnaty should be approved for use in this age group.
The expansion of Comirnaty CMA indications is valid in all 27 member states of the European Union.
com/tags/%E8%BE%89%E7%91%9E/">The conditional marketing authorization (CMA) of bioon.
com/tags/%E8%BE%89%E7%91%9E/">Pfizer COVID-19 mRNA vaccine Comirnaty (BNT162b2) in the EU has been extended to include adolescents aged 12-15
Comirnaty is the first COVID-19 vaccine authorized in the European Union and the first vaccine to extend its CMA to adolescents.
The distribution and vaccination of Comirnaty in EU member states will continue to be implemented in accordance with the population determined by the EU and the guidelines of each country.
The distribution and vaccination of Comirnaty in EU member states will continue to be implemented in accordance with the population determined by the EU and the guidelines of each country.
In the United States, on May 10 this year, the FDA approved the expansion of Comirnaty's emergency use authorization (EUA) to include 12-15 year olds.
It is worth mentioning that Comirnaty is the first COVID-19 vaccine approved for this age group in the United States .
Previously, the FDA has granted Comirnaty an EUA for active immunization of people ≥16 years of age.
It is worth mentioning that Comirnaty is the first COVID-19 vaccine approved for this age group in the United States .
Previously, the FDA has granted Comirnaty an EUA for active immunization of people ≥16 years of age.
Comirnaty is the first COVID-19 vaccine authorized in the European Union and the first vaccine to extend its CMA to adolescents.
The distribution and vaccination of Comirnaty in EU member states will continue to be implemented in accordance with the population determined by the EU and the guidelines of each country.
Comirnaty is the first COVID-19 vaccine authorized in the European Union and the first vaccine to extend its CMA to adolescents. The distribution and vaccination of Comirnaty in EU member states will continue to be implemented in accordance with the population determined by the EU and the guidelines of each country.
In the United States, on May 10 this year, the FDA approved the expansion of Comirnaty's emergency use authorization (EUA) to include 12-15 year olds.
It is worth mentioning that Comirnaty is the first COVID-19 vaccine approved for this age group in the United States .
Previously, the FDA has granted Comirnaty an EUA for active immunization of people ≥16 years of age.
Comirnaty is the first COVID-19 vaccine approved for this age group in the U. It is worth mentioning that Comirnaty is the first COVID-19 vaccine approved for this age group in the United States .
Previously, the FDA has granted Comirnaty an EUA for active immunization of people ≥16 years of age.
S.
BioNTech CEO and co-founder Ugur Sahin, MD, said: "Today, we have expanded the authorization of the COVID-19 vaccine in the European Union.
This is another important milestone in our joint efforts to expand the vaccination program to as many people as possible.
Providing adolescents with vaccines will help reopen schools and help return to normal daily life.
"
This is another important milestone in our joint efforts to expand the vaccination program to as many people as possible.
Providing adolescents with vaccines will help reopen schools and help return to normal daily life.
"
Albert Bourla, Chairman and CEO of Pfizer, said: “This is a meaningful moment for teenagers, parents, and the entire family.
They are seeking protection from this virus and returning to their normal lives.
We appreciate this The agency has thoroughly and effectively reviewed our bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trial data and looks forward to seeing more people across Europe being vaccinated as a result of today’s decision.
”
bioon. They are seeking protection from this virus and returning to their normal lives.
We appreciate this The agency has thoroughly and effectively reviewed our bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trial data and looks forward to seeing more people across Europe being vaccinated as a result of today’s decision.
”
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical Trials
The decisions of the US and EU regulators are based on data from a key Phase 3 bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trial .
This is a multi-country, placebo-controlled, observer-blinded trial, enrolling 2260 adolescent subjects aged 12-15 years old.
These subjects were randomly assigned at a ratio of 1:1 and vaccinated with Comirnaty (N=1131, 2 doses, 30μg, 21 days apart) or placebo (n=1129, 2 doses, 21 days apart).
bioon. com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trial .
This is a multi-country, placebo-controlled, observer-blinded trial, enrolling 2260 adolescent subjects aged 12-15 years old.
These subjects were randomly assigned at a ratio of 1:1 and vaccinated with Comirnaty (N=1131, 2 doses, 30μg, 21 days apart) or placebo (n=1129, 2 doses, 21 days apart).
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical Trials
The results of the test were published in the international medical journal New England Journal of Medicine (NEJM) on May 27, 2021, with the title of the article: Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents .
The data shows that regardless of whether there is a previous SARS-CoV-2 infection, the vaccine's efficacy in subjects is 100%, and a strong antibody response is generated.
In this trial, the vaccine also showed good tolerance.
After the second dose of vaccine, these subjects will continue to receive an additional 2 years of long-term protection and safety monitoring.
Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents Regardless of whether there is a previous SARS-CoV-2 infection, the vaccine is 100% effective in subjects and produces a strong antibody response. The data shows that regardless of whether there is a previous SARS-CoV-2 infection, the vaccine's efficacy in subjects is 100%, and a strong antibody response is generated.
In this trial, the vaccine also showed good tolerance.
After the second dose of vaccine, these subjects will continue to receive an additional 2 years of long-term protection and safety monitoring.
In addition, pediatric studies evaluating the safety and effectiveness of Comirnaty in children 6 months to 11 years of age are ongoing.
Pfizer and BioNTech are expected to obtain definite results in September, and based on the data generated, submit emergency use authorization (such as in the United States) or conditional marketing authorization for 2 cohorts (including children aged 2-5 and 5-11) Changes (such as in the European Union).
The results of the 6-month to 2-year-old cohort are expected to be released and submitted in the fourth quarter of this year.
Pfizer and BioNTech are expected to obtain definite results in September, and based on the data generated, submit emergency use authorization (such as in the United States) or conditional marketing authorization for 2 cohorts (including children aged 2-5 and 5-11) Changes (such as in the European Union).
The results of the 6-month to 2-year-old cohort are expected to be released and submitted in the fourth quarter of this year.
Comirnaty vaccine (Image source: haber7.
net)
net)
Pfizer/BioNTech’s COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology and is jointly developed by BioNTech and Pfizer.
BioNTech is the EU marketing authorization holder, before planning to apply for full marketing authorization in the United States (together with Pfizer), the United Kingdom, Canada and other countries, it is the holder of an emergency use authorization (EUA) or equivalent authorization in these countries.
BioNTech is the EU marketing authorization holder, before planning to apply for full marketing authorization in the United States (together with Pfizer), the United Kingdom, Canada and other countries, it is the holder of an emergency use authorization (EUA) or equivalent authorization in these countries.
At present, the Comirnaty vaccine has not been approved or licensed by the US FDA, but has obtained an emergency use authorization (EUA) from the bioon.
com/fda/" target="_blank">FDA : it is used for active immunization of people ≥ 12 years old to prevent the new type of coronavirus caused by the new type of coronavirus (SARS-CoV-2) Viral pneumonia (COVID-19).
bioon. com/fda/" target="_blank">FDA : it is used for active immunization of people ≥ 12 years old to prevent the new type of coronavirus caused by the new type of coronavirus (SARS-CoV-2) Viral pneumonia (COVID-19).
com/fda/" target="_blank">FDA
On May 7 this year, Pfizer and BioNTech announced that they have initiated the rolling submission of Comirnaty's biological product license application (BLA) to the US FDA for active immunization of people ≥16 years of age.
The data supporting the BLA will be submitted to the bioon.
com/fda/" target="_blank">FDA in a rolling form in the next few weeks and will require priority review.
()
bioon. The data supporting the BLA will be submitted to the bioon.
com/fda/" target="_blank">FDA in a rolling form in the next few weeks and will require priority review.
()
com/fda/" target="_blank">FDA
Original source: Pfizer and BioNTech Receive First Authorization in European Union for COVID-19 Vaccine in Adolescents
