BioNTech Archives - Page 14 of 20 - Medical Design Sourcing

Pfizer and BioNTech seek EMA nod for younger adolescents

After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking authorization from the European Medicines Agency (EMA) to distribute the vaccine to that age group.

BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries starting in June.

The companies requested in early April that FDA lower the vaccine eligibility from 16 to 12 years of age.

Get the full story from our sister site, Drug Discovery & Development.

Side effects relatively rare for Pfizer-BioNTech vaccine, study says

A recent study found that only 13.5% of recipients of the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) had systemic side effects after the first dose. That figure climbed to 22.0% after the second dose.

Conversely, just over one-third (33.7%) of recipients of the first dose of vaccine from AstraZeneca (LON:AZN) had systemic side effects, according to the study published in The Lancet. The study didn’t have data regarding the adverse events from the second AstraZeneca dose.

Get the full story from our sister site, Drug Discovery & Development.

Side effects relatively rare for Pfizer-BioNTech vaccine: Study

A recent study found that only 13.5% of recipients of the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) had systemic side effects after the first dose. That figure climbed to 22.0% after the second dose.

Conversely, just over one-third (33.7%) of recipients of the first dose of vaccine from AstraZeneca (LON:AZN) had systemic side effects, according to the study published in The Lancet.

Among those with a prior COVID-19 infection, however, systemic side effects were 2.9 times more common in recipients of the first Pfizer vaccine than those who were infection naive. For recipients of the first dose of the AstraZeneca vaccine, such side effects were 1.6 times more common in those previously infected with COVID-19.

The study, which involved 627,383 participants, ran from Dec. 8 to March 10.

Local side effects (frequently injection-site pain and tenderness) were more common than systemic events, occurring in 71.9% of recipients of th…

Pfizer and BioNTech seek EMA nod for younger adolescents

Image courtesy of Wikipedia

After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking E.U. authorization to distribute the vaccine to that age group.

BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries starting in June.

The companies requested in early April that FDA lower the vaccine eligibility from 16 to 12 years of age.

Janet Woodcock, FDA’s acting commissioner, vowed to review the request “as expeditiously as possible using our thorough and science-based approach” but declined to estimate how long it would take to do so.

BioNTech and its partner Pfizer are currently overseeing vaccine clinical trials for children as young as six months old.

The companies also plan on asking other international regu…

Study: Single dose of Pfizer or AstraZeneca COVID-19 vaccine cuts infection risk by 65%

[Photo by Daniel Schludi on Unsplash]

One dose of vaccine from Pfizer (NYSE:PFE) or AstraZeneca (LON:AZN) leads to a substantial reduction in infection risk in adults, according to a recent study published in BMJ.

The study organizers found that recipients of a single dose of either vaccine led to a 57% reduction in asymptomatic infections and a 74% drop in symptomatic disease at least 21 days after vaccination. The overall risk reduction was thus 65%.

A second dose of the vaccine from Pfizer and its partner BioNTech (NSDQ:BNTX) reduced the risk of infection by 70% in the study. There was insufficient data to assess the efficacy of the AstraZeneca vaccine after the second dose.

The researchers concluded that when vaccine supplies are limited, health systems should prioritize vaccinating those who have not yet been infected with COVID-19 while prioritizing giving second doses to those 60 and o…

More than 5 million skipped getting second COVID-19 vaccine dose

Pfizer-BioNTech vaccine image courtesy of Wikipedia

The percentage of people who failed to get the second dose of Pfizer or Moderna COVID-19 vaccines is growing, according to recent CDC data. Some five million people, or almost 8% of people who got the first vaccine dose, missed getting the second.

In mid-March, 3% of people were overdue for their second dose.

People who missed getting their second vaccine dose provided several explanations. Some wanted to avoid adverse events, which are more common after the second dose. Others believed a single dose offered sufficient protection.

Another contributing factor relates to supply constraints at vaccination sites, which are instructed not to use Moderna and Pfizer vaccines interchangeably.

The supply constraints are likely to ease the number of people making appointments for COVID-19 vaccination falls in many parts of the country.

Som…

Israel investigating heart inflammation cases in Pfizer COVID-19 vaccine recipients

Histopathology of myocarditis. [Image courtesy of Wikipedia]

Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

More than five million people in the country have received the vaccine.

The agency, however, has not yet established a causal relationship between the events and the vaccine.

Get the full story from our sister site, Drug Discovery & Development.

Israel investigating heart inflammation cases in Pfizer COVID-19 vaccine recipients

Histopathology of myocarditis. [ Image courtesy of Wikipedia]

Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

More than five million people in the country have received the vaccine.

The agency, however, has not yet established a causal relationship between the events and the vaccine.

Pfizer has also reported that it has not observed a higher rate of myocarditis among vaccine recipients than in the general population.

The Israeli data suggest that myocarditis reports may be more common after the second vaccine dose.

Most of the people with myocarditis were 30 years old or younger.

Establishing causation for myocarditis can be challenging. Researchers have linked the condition to an array of pathogens, including viruses, bacteria and …

EU secures additional 100 million Pfizer-BioNTech vaccine doses

The European Union has decided to exercise an option to purchase additional doses of the Comirnaty COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

The two companies will deliver 600 million doses of the vaccine to the EU in 2021.

The Continent’s mass-vaccination efforts have sputtered for much of early 2021, given supply constraints related to the AstraZeneca vaccine and, later, safety concerns related to rare blood clotting problems potentially linked to that vaccine.

In related news, Sweden and several other EU nations are negotiating with Russia to procure that country’s Sputnik V vaccine. The idea behind those talks is to prepare for when the European Medicines Agency authorizes that vaccine.

The EU nations Hungary and Slovakia had already obtained a substantial number of doses of the vaccine, but Russia had asked Slovakia to return hundreds of millions of doses earlier this month, citing contract violations, Reuters repo…

Annual COVID-19 vaccines likely, according to Pfizer CEO

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.

While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on an mRNA platform.

Get the full story from our sister site, Drug Discovery & Development.

Annual COVID-19 vaccines likely, according to Pfizer CEO

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.

While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on an mRNA platform.

Adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson are currently in limited use, given concerns that they could cause rare but serious blood clotting problems.

The mRNA vaccines from Moderna and Pfizer/BioNTech also have a head start, and U.S. officials expect 600 million doses of the vaccines to be delivered by the end of July.

It will be “a stretch for adenoviral-vector vaccines to have any material uptake,” in the U.S., said Navin Jacob, a senior equity research analyst at UBS. “And you can’t really give boosters with the adenoviral-vector vaccin…

EU won’t renew J&J, AstraZeneca vaccine contracts, report says

[Photo by Daniel Schludi on Unsplash]Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson.

According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the current year expire, with Brussels reportedly emphasizing its focus on mRNA vaccines like those produced by Pfizer/BioNTech and Moderna.

Get the full story at our sister site, Drug Discovery & Development.