U.S. Trade Representative Katherine Tai announced this afternoon that the Biden administration supports waiving IP protections for COVID-19 vaccines.
“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement.
Get the full story on our sister site Pharmaceutical Processing World.
U.S. Trade Representative Katherine Tai announced on Twitter that the Biden administration supports a COVID-19 vaccine IP waiver.
Stocks of major COVID-19 vaccine makers Moderna and Pfizer are down today after U.S. Trade Representative Katherine Tai announced that the Biden administration supports waiving IP protections for COVID-19 vaccines.
“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement.
Tai said the U.S. will actively participate in World Trade Organization text-based negotiations to make the IP protections waiver happen, though she added that such discussions will take time given the complexity of the WTO.
Moderna (Nasdaq:MRNA) shares are down more than –6% to $162.76 apiece, and Pfizer shares are down more than –1% to $39.53 apiece on the news this afternoon.
Even a…
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.
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…
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…
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.
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.
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…
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…
Moderna (NSDQ:MRNA) announced today that it committed funds to increase its COVID-19 vaccine manufacturing capacity to up to 3 billion doses for 2022.
Cambridge, Mass.-based Moderna’s new funding commitments are slated to increase supply at its owned and partnered manufacturing facilities up to that 3 billion-dose capacity, depending upon the mix between the authorized Moderna COVID-19 vaccine at the 100 μg dose level and potentially lower doses of the Company’s variant booster candidates and pediatric vaccines, if authorized, according to a news release.
Get the full story at our sister site, Pharmaceutical Processing World.
Moderna (NSDQ:MRNA) announced today that it committed funds to increase its COVID-19 vaccine manufacturing capacity to up to 3 billion doses for 2022.
Cambridge, Mass.-based Moderna’s new funding commitments are slated to increase supply at its owned and partnered manufacturing facilities up to that 3 billion-dose capacity, depending upon the mix between the authorized Moderna COVID-19 vaccine at the 100 μg dose level and potentially lower doses of the Company’s variant booster candidates and pediatric vaccines, if authorized, according to a news release.
The company said it plans to use its existing cash balance to fund the investments into the increased manufacturing, which will see the doubling of drug substance manufacturing at Lonza’s Switzerland-based facility, more than double the formulation, fill/finish and drug substance manufacturing at Rovi’s Spain facility and a 50% increase in drug substance at Moderna’s U.S. plants.
Pfizer-BioNTech vaccine image courtesy of Wikipedia
Signs are growing that COVID-19 vaccine boosters will be required to fight waning immunity and SARS-CoV-2 variants.
An article recently published in NEJM describes how SARS-CoV-2 variants managed to cause breakthrough infection in two patients fully immunized with mRNA vaccines. The 15 authors support “efforts to advance a new vaccine booster (as well as a pan-coronavirus vaccine) to provide increased protection against variants.”
While such breakthrough infections remain rare, they may grow more common as immunity from vaccines wanes. Data suggests that mRNA vaccines offer strong protection for at least six months. It is likely that immunity will wane sometime in another six to 12 months.
Pfizer CEO Dr. Albert Bourla has said that boosters of the vaccine will likely be necessary, as did BioNTech cofounders Dr. Ugur Sahin and Dr. Özlem Türeci.…