BioNTech Archives - Page 13 of 20 - Medical Design Sourcing

Exelead makes first precursor batch of Pfizer-BioNTech COVID-19 vaccine

Pharma industry contract manufacturer Exelead recently announced that it has delivered its first precursor batch of Prizer-BioNTech’s COVID-19 vaccine, produced at its recently expanded facility in Indianapolis.

Exelead plans to add 50 jobs to help it meet COVID-19 vaccine demand.

“We are extremely proud to be part of the manufacture of the Pfizer-BioNTech COVID-19 vaccine, knowing our work has the potential to help millions of people,” said Exelead CEO John Rigg said in a news release. “As a leader in complex drug manufacturing, Exelead is committed to leveraging our manufacturing capabilities and years of experience to help support the supply of the Pfizer-BioNTech COVID-19 vaccine and increase the number of doses available.”

Kevin Nepveux, VP of Pfizer Global Supply, added that contract manufacturer support is one way the pharmaceutical giant has ramped up manufacturing capabilities to produce more COVID-19 vaccine doses.

CureVac and GSK announce promising preclinical data for next-gen COVID-19 vaccine

As CureVac (NSDQ:CVAC) awaits European authorization for its mRNA COVID-19 vaccine, it is conducting preclinical research on a second-generation vaccine candidate known as CV2CoV, which it is developing with GSK.

In a study involving rats, the new mRNA vaccine candidate yielded high levels of antigen and strong neutralizing antibody titers after the first vaccination.

Tübingen, Germany–based CureVac also said the vaccine candidate led to high levels of antibodies against several variants of concern, including B.1.1.298, B.1.1.7 and B.1.351.

“To successfully fight the COVID-19 pandemic in the long term, we will need different vaccines, and we need to be able to respond effectively to emerging variants,” GSK Global Vaccines President Roger Connor said in a statement.

CV2CoV uses a new mRNA platform than CureVac’s first COVID-19 vaccine candidate known as CVnCoV. The new platform intends to bolster intracellular mRNA stability and translation to y…

FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine also had favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

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

FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine also had favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” wrote Acting FDA Commissioner Janet Woodcock, MD, in prepared remarks. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

An advisory committee of the Centers for Disease Control and Pr…

Moderna shares positive data regarding COVID-19 vaccine boosters

Vials containing the Moderna COVID-19 vaccine. [Image from Wikipedia]

Initial data from a Moderna (NSDQ:MRNA) Phase 2 trial found two versions of its COVID-19 vaccine increased neutralizing titers against SARS-CoV-2 and two variants in previously vaccinated clinical trial volunteers.

A third dose of the company’s existing mRNA-1273 appears to improve immune response against the B.1.351 variant that first emerged in South Africa. But a booster dose of mRNA-1273.351, which was developed based on the South African variant, led to higher titers against B.1.351. Both vaccines also appear to offer superior protection against P.1, the lineage first identified in Brazil.

Moderna announced that both boosters were generally well tolerated.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have a Phase 1/2/3 trial underway testing the use of a third dose of their COVID-19 vaccine. The two companies have also plan…

BREAKING: Biden administration calls for waiving IP protections for COVID-19 vaccines

U.S. Trade Representative Katherine Tai announced on Twitter that the Biden administration supports a COVID-19 vaccine IP waiver.

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.

BREAKING: Biden administration calls for waiving IP protections for COVID-19 vaccines

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 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).

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…