coronavirus Archives - Page 35 of 99 - Medical Design Sourcing

Novavax vaccine 51% effective against the South African variant

A Phase 2a-b trial found that the Novavax (NASDAQ: NVAX) NVX-CoV2373 vaccine was 51% effective against the B.1.351 variant in HIV-negative participants without evidence of prior SARS-CoV-2 infection.

The overall vaccine efficacy against SARS-CoV-2 was 49% and 60% for HIV-negative participants, according to the study published in NEJM.

The study authors note that the efficacy figures are preliminary.

The study’s primary efficacy endpoint was protection against laboratory-confirmed COVID-19 seven or more days after administration of the second dose.

The study involved 4,387 participants.

An earlier study found that the vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus. That figure dropped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7) and 49% against the B.1.351 variant.

The Novavax vaccine differs from others that are currently available. Namely, it is a recombi…

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…

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…

FDA revokes Battelle mask decontamination EUA

The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers.

In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. Battelle said it is no longer operating or marketing the vaporized hydrogen peroxide systems, according to the revocation letter.

Get the full story on our sister site, Medical Design & Outsourcing.

MedTech 100 roundup: Return to normal following recent spike

After back-to-back all-time best performances, the medtech industry had a slight regression over the course of the last week.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been continuously ticking up since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index topped itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week. However, things have settled down and the industry responded in kind, dipping -1.6% to 112.7 to end last week (April 30).

In spite of the slight decrease over the past week, the industry continues to reflect a bounceback from the struggles brought on by the COVID-19 pandemic.

Overall, has produced a 22.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 81.4% increase from…

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.