mRNA vaccines do not negatively affect sperm county, study finds

One of the many urban legends related to COVID-19 vaccines is that they cause infertility. Researchers at the University of Miami set out to disprove that claim with a recent single-center prospective study. Unsurprisingly, the study that indicated the mRNA vaccines have no negative impact on male fertility. In fact, the researchers found that after the second vaccine dose, participants exhibited a significant increase in median sperm concentration and sperm motility.

In the study published in JAMA, the researchers stopped short of claiming that mRNA COVID-19 vaccines could boost fertility in men. “While these results showed statistically significant increases in all sperm parameters, the magnitude of change is within normal individual variation,” the study authors concluded.

The study only evaluated the BNT162b2 and mRNA-1273 vaccines from Pfizer-BioNTech and Moderna, respectively.

The study tracked participants approximately 70 days after administering…

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CureVac marches on after announced disappointing study results

After CureVac (NSDQ:CVAC) revealed that its first-generation vaccine candidate has an interim efficacy of 47% in a pivotal trial, its stock lost about half its value. The company, however, is undeterred.

Speaking in a call with investors and analysts, CureVac CEO Franz-Werner Haas said the company would continue to seek the authorization of its CVnCoV vaccine and continue developing its next-generation CV2CoV vaccine.

One difference between the vaccine from CureVac and those from Moderna and Pfizer-BioNTech lies in the dose of mRNA. The CureVac vaccine contains 12 µg of mRNA per dose. The Pfizer-BioNTech vaccine uses 30 µg per shot, while the Moderna vaccine contains 100 µg.

Haas, however, stressed the role of virus variants in the 47% interim efficacy figure. The Phase 2b/3 study “provides important insights into a dramatically transformed variant environment, suggesting that we are virtually fighting a different virus — a different pandemic” than six m…

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U.S. buys 200 million more Moderna vaccine doses for potential boosters and use in children

Health experts remain divided over the need for COVID-19 vaccine boosters in the coming months, but the U.S. government is preparing for that possibility by purchasing 200 million additional doses of the COVID-19 vaccine from Moderna (NSDQ:MRNA).

The purchase of additional doses will also enable the U.S. government to inoculate children aged 12 to 17 in coming months, assuming FDA authorizes that use. Two doses of the vaccine were 100% effective in that age group, according to a recent Phase 2/3 trial.

In May, FDA amended its EUA for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15.

The U.S. has committed to buying 500 million doses of Moderna’s vaccine to date. The company expects to deliver 110 million doses in the fourth quarter of 2021 and another 90 million in the first quarter of 2022.

To date, Moderna has provided 217 million doses to the U.S.

The NIH has launched a clinical trial involving fully vaccinated participan…

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CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

CureVac’s stock dropped 3.47% to $94.79 per share after the company announced the news.

The company anticipates that a final analysis will be ready in a matter of weeks. Based on available data, the vaccine appears to have a favorable safety profile.

CureVac is partnering with GSK (NYSE:GSK) to develop a next-gen COVID-19 vaccine. That vaccine could potentially protect against multipl…

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Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.

[Related: 50 of 2020’s best-selling pharmaceuticals]

A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven pa…

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Almost one-quarter of Americans remain vaccine-hesitant

[Photo by Maksim Goncharenok from Pexels]

A study from Informa Pharma Intelligence and YouGov concluded that vaccine hesitancy remains a significant hurdle in the U.S. A separate study published in JAMA indicates vaccine hesitancy is falling. Specifically, the number of people who were suspicious about COVID-19 vaccines fell from 46% in October 2020 to 35% in March 2021.

Conversely, the Informa-YouGov survey from April 21 and 22 concluded that 23% of Americans were vaccine-hesitant. The study had 1,327 adult participants.

While approximately half of the U.S. public has received at least one vaccine dose, vaccinating the remainder of the eligible population could be a hurdle.

But the recent data from the Informa-YouGov survey indicate that achieving President Biden’s goal of providing at least one vaccine dose to 70% of the American adults by July 4 is at least feasible.

Another factor tha…

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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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