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Pfizer/BioNTech stated that the co-developed COVID-19 vaccine is very effective in preventing symptomatic COVID-19 infection, with a protection period of up to six months after the second vaccination.
On April 1, Pfizer and BioNTech jointly stated that the new crown vaccine jointly developed by the two is very effective in preventing symptomatic new crown infection.
After the second dose, the protection period is up to 6 months, and the effective rate is still 91.
3%.
.
The results announced on Thursday come from ongoing evaluations of the performance of volunteers in later trials of the vaccine.
Pfizer and BioNTech said that further analysis showed that the vaccine is effective against the mutant strain first discovered in South Africa.
The two companies also stated that no serious security issues have been found so far.
A total of 46,307 volunteers participated in the trial.
Of the 927 subjects infected with new coronary pneumonia, only 77 received the Pfizer vaccine, while 850 received a placebo.
According to the latest survey results, among the 12,000 volunteers at least six months after the second vaccination, there are no serious safety hazards.
But there are many typical short-term side effects, such as fatigue and arm soreness.
This study also shows that the vaccine is effective against a virus variant named B.
1.
351 that was first discovered in South Africa.
The study found that about 800 trial participants were from South Africa, and 9 of them were infected with the new crown, all belonging to the placebo group.
The company sequenced the genes of all nine infected people and found that six of them belonged to the B.
1.
351 variant.
The statement stated that the vaccine has an effective rate of 100% against serious diseases defined by the CDC in the United States, and an effective rate of 95.
3% against severe COVID-19 defined by the US FDA. Safety data from the Phase 3 study was also collected from more than 12,000 vaccinated participants.
These participants had a follow-up period of at least six months after the second dose, demonstrating good safety and tolerability.
Sex.
The FDA is also expected to review the authorization applications of AstraZeneca and Oxford University for the vaccine they have developed in the next few days.
The FDA and the Centers for Disease Control and Prevention have slightly different definitions of "serious disease.
"
According to the FDA's definition, there were 21 serious illnesses, of which 20 received a placebo.
According to the study, under the definition of the Centers for Disease Control and Prevention, 32 trial participants suffered from serious illnesses, and all of them belonged to the placebo group.
The new data may be sufficient to enable the vaccine to meet the full approval standards set by the US FDA.
So far, all three approved COVID-19 vaccines in the United States: Pfizer-BioNTech, Moderna, and Johnson & Johnson-are all distributed under emergency use authorization instead of obtaining a full FDA biologics license because they do not have long-term safety and effectiveness data.
The FDA allows companies to provide only two months of data so that the new crown vaccine can be made available to the public more quickly in a global emergency.
The agency said that once the vaccine has a track record of at least six months, it will consider issuing a full license-the same as the requirements for vaccines to prevent other infectious diseases.
Pfizer and BioNTech said on Wednesday that they will require the FDA to approve the provision of vaccines to teenagers between the ages of 12 and 15.
The vaccine has been authorized for use in older teenagers, and new data shows that it is equally safe and protective for younger teenagers.
Pfizer and BioNTech plan to submit the new data to peer-reviewed journals for review and publication.
They will continue to follow participants for two years to ensure safety and effectiveness, and begin to answer the last major unanswered question about the new crown vaccine: how long will they remain effective.
On April 1, Pfizer and BioNTech jointly stated that the new crown vaccine jointly developed by the two is very effective in preventing symptomatic new crown infection.
After the second dose, the protection period is up to 6 months, and the effective rate is still 91.
3%.
.
The results announced on Thursday come from ongoing evaluations of the performance of volunteers in later trials of the vaccine.
Pfizer and BioNTech said that further analysis showed that the vaccine is effective against the mutant strain first discovered in South Africa.
The two companies also stated that no serious security issues have been found so far.
A total of 46,307 volunteers participated in the trial.
Of the 927 subjects infected with new coronary pneumonia, only 77 received the Pfizer vaccine, while 850 received a placebo.
According to the latest survey results, among the 12,000 volunteers at least six months after the second vaccination, there are no serious safety hazards.
But there are many typical short-term side effects, such as fatigue and arm soreness.
This study also shows that the vaccine is effective against a virus variant named B.
1.
351 that was first discovered in South Africa.
The study found that about 800 trial participants were from South Africa, and 9 of them were infected with the new crown, all belonging to the placebo group.
The company sequenced the genes of all nine infected people and found that six of them belonged to the B.
1.
351 variant.
The statement stated that the vaccine has an effective rate of 100% against serious diseases defined by the CDC in the United States, and an effective rate of 95.
3% against severe COVID-19 defined by the US FDA. Safety data from the Phase 3 study was also collected from more than 12,000 vaccinated participants.
These participants had a follow-up period of at least six months after the second dose, demonstrating good safety and tolerability.
Sex.
The FDA is also expected to review the authorization applications of AstraZeneca and Oxford University for the vaccine they have developed in the next few days.
The FDA and the Centers for Disease Control and Prevention have slightly different definitions of "serious disease.
"
According to the FDA's definition, there were 21 serious illnesses, of which 20 received a placebo.
According to the study, under the definition of the Centers for Disease Control and Prevention, 32 trial participants suffered from serious illnesses, and all of them belonged to the placebo group.
The new data may be sufficient to enable the vaccine to meet the full approval standards set by the US FDA.
So far, all three approved COVID-19 vaccines in the United States: Pfizer-BioNTech, Moderna, and Johnson & Johnson-are all distributed under emergency use authorization instead of obtaining a full FDA biologics license because they do not have long-term safety and effectiveness data.
The FDA allows companies to provide only two months of data so that the new crown vaccine can be made available to the public more quickly in a global emergency.
The agency said that once the vaccine has a track record of at least six months, it will consider issuing a full license-the same as the requirements for vaccines to prevent other infectious diseases.
Pfizer and BioNTech said on Wednesday that they will require the FDA to approve the provision of vaccines to teenagers between the ages of 12 and 15.
The vaccine has been authorized for use in older teenagers, and new data shows that it is equally safe and protective for younger teenagers.
Pfizer and BioNTech plan to submit the new data to peer-reviewed journals for review and publication.
They will continue to follow participants for two years to ensure safety and effectiveness, and begin to answer the last major unanswered question about the new crown vaccine: how long will they remain effective.