CureVac’s COVID-19 vaccine candidate inches forward to Phase 2b/3 efficacy readout

CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready.

The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular COVID-19 vaccines in the world.

The data and safety monitoring board also concluded that there were no safety concerns linked to the CVnCoV in the HERALD study.

The company’s second-generation vaccine is known as CV2CoV, which it is developing in collaboration with GSK.

 

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Sinopharm publishes COVID-19 vaccine trial data

An article recently published in JAMA concluded that two inactivated COVID-19 vaccines from Sinopharm (OTCMKTS: SHTDY) were 72.8% and 78.1% effective, respectively, based on interim Phase 3 study results.  

The lower figure refers to the protection from a COVID-19 vaccine based on two 5-µg doses based on the SARS-CoV-2 isolate WIV04 complete genome. The second vaccine in the study was based on two 4-µg vaccine doses developed with the HB02 strain of SARS-CoV-2. Some 13,459 received the WIV04-based vaccine, while 13,465 received the HBO2 version. 

A placebo group including 13,465 participants received aluminum hydroxide, a common adjuvant.

In all, the study involved 40,380 participants. Most participants in the study were relatively young men.

Sinopharm recruited study participants in the United Arab Emirates, Egypt, Jordan and Bahrain. The study population consisted of adults at least 18 years of age who believed they had not contracted COVID-19 o…

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COVID-19 vaccine booster questions remain

Image from Nataliya Vaitkevich via Pexels

While the question of when the vaccinated public will require a COVID-19 booster remains unclear, some long-term care advocates are pushing for guidance to avoid a potential resurgence in infections in the fall and winter. 

Nursing home residents were among the first to receive COVID-19 vaccines. Providing boosters to the demographic is vital to prevent the spread of COVID-19 infections, which was a significant driver of overall mortality from the novel coronavirus at the beginning of the pandemic. “Hence, if and when the residents’ immunity wanes, we must be on high alert, lest we relive the horrors of the past year,” said Dr. Mike Wasserman, a member of California’s Vaccine Advisory Committee in an interview with ABC News. 

Complicating matters is the fact that many older adults have a diminished ability to produce antibodies, increas…

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Sanofi and GSK start Phase 3 trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.

The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.

Prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults constitutes the primary endpoint, while the prevention of severe COVID-19 disease and prevention of asymptomatic infection makes up the secondary endpoints.

Stage one of the study will investigate the efficacy of the vaccine formulation targeting the original D.614 virus (Wuhan) while a second stage will evaluate a second formulation targeting the South African (B.1.351) variant. The global study offers a chance to evaluate the vaccine candidate against a number of circulatin…

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FDA could decline new COVID-19 vaccine EUA requests

Healthcare workers have administered almost 288 million doses of COVID-19 vaccines in the U.S., which now has more than enough vaccine for the present demand. 

Against that backdrop, FDA has released updated emergency use authorization (EUA) guidelines for COVID-19 vaccines that state the agency could decline some future EUA requests. “For the remainder of the current pandemic, FDA may decline to review and process further EUA requests other than those for vaccines whose developers have engaged in an ongoing manner with the Agency,” the guidelines explain. 

In its most recent guidance, the FDA also stresses the need for EUA vaccine candidates to undergo rigorous product quality review, including scrutiny of manufacturing and clinical trials. 

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have already begun filing a Biologics License Application for full FDA approval for their COVID-19 vaccine. Moderna (NSDQ:MRNA) is also pursuing full approval. …

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Moderna’s COVID-19 vaccine 100% effective in teens

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) has joined Pfizer (NYSE:PFE) in announcing that its vaccine was 100% effective in a Phase 2/3 study involving adolescents. It will seek regulatory authorization to expand the use of its vaccine to adolescents as young as 12 in early June.

In the TeenCOVE study, no participants who received two doses of the mRNA-1273 vaccine contracted symptomatic COVID-19.

Using a secondary CDC case definition of COVID-19 that includes milder illness, the trial found that the vaccine was 93% effective in seronegative participants. The secondary case definition requires the presence of one COVID-19 symptom and a positive reverse transcription-polymerase chain reaction (RT-PCR) test. The company used that definition because COVID-19 transmission in adolescents is lower than in adults.

Side effects in the trial were generally mild or moderate for v…

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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…

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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. 

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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…

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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…

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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…

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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.

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