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Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2

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Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine.

Speaking during the company’s first-quarter earnings call yesterday, which was transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is currently available to Americans 16 years of age and older through FDA emergency use authorization (EUA).

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

Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2

Image courtesy of Wikipedia

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine.

Speaking during the company’s first-quarter earnings call yesterday, which was transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is currently available to Americans 16 years of age and older through FDA emergency use authorization (EUA).

Bourla said the company is submitting a Biologics License Application to the FDA in search of full approval for the vaccine in individuals 16 years of age and older and plans to submit for EUA for two cohorts — children between age 2-5 and children between age 5-11 — in September 2021.

The company is awaiting a response from the FDA regarding its application for expanded EUA that would ext…

Canadian federal advisory committee prefers mRNA COVID-19 vaccines

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Canada’s National Advisory Council on Immunization (NACI) has recommended that Canadians wait to receive the messenger RNA (mRNA) vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) when feasible. The advice stands in contrast to prior guidance that Canadians seek the first-available vaccines.

“What we’re saying and what we’ve said all along is that mRNA vaccines are the preferred vaccine,” said NACI’s co-chair, Dr. Shelley Deeks.

Canada had recently put on hold plans to distribute 300,000 doses of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ). The reason for the move lies in J&J’s contract manufacturing partner, Emergent BioSolutions (NYSE:EBS), which inadvertently ruined 15 million doses of the vaccine.

NACI has recommended the J&J vaccine for those over the age of 30 where mRNA vaccine suppl…

FDA could soon authorize Pfizer COVID-19 vaccine for younger adolescents

The COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) appears to be on the cusp of winning regulatory authorization for use in adolescents between the ages of 12 and 15, according to several media reports. FDA has authorized the vaccine for people aged 16 and up.

In March, Pfizer submitted clinical trial results to FDA, suggesting the efficacy of the vaccine was 100% for adolescents aged 12 to 15 based on a trial involving more than 2,000 participants. The reactogenicity of the vaccine in younger adolescents was also favorable.

The European Medicines Agency is also considering making the vaccine available to younger adolescents.

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

FDA could soon authorize Pfizer COVID-19 vaccine for younger adolescents

The COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) appears to be on the cusp of winning regulatory authorization for use in adolescents between the ages of 12 and 15, according to several media reports. FDA has authorized the vaccine for people aged 16 and up.

In March, Pfizer submitted clinical trial results to FDA, suggesting the efficacy of the vaccine was 100% for adolescents aged 12 to 15 based on a trial involving more than 2,000 participants. The reactogenicity of the vaccine in younger adolescents was also favorable.

The European Medicines Agency is also considering making the vaccine available to younger adolescents.

The news comes as vaccination rates in the U.S. fall while Europe’s vaccination efforts are picking up pace after months of sputtering.

In the U.S., the availability of the vaccine to children 12 and older would enable widespread vaccination before the beginning of the next school year.

Pfizer and Bio…

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.