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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Recent study finds Pfizer vaccine effective against Delta variant

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) leads to a strong neutralizing antibody response to the B.1.617 variant, according to a recent study published in Nature. 

The study focused on the B.1.617.2 subtype of the virus. Two others exist, known as B.1.617.1 and B.1.617.3. 

The study did acknowledge that the antibody response to the B.1.617 was less robust than it was for the USA-WA1/2020 strain. 

The study concluded that mass immunization with the BNT162b2 vaccine should be a central strategy to end the pandemic. 

Researchers first identified the B.1.617 variant in India. The so-called Delta variant now accounts for approximately 6% of COVID-19 infections in the U.S. It is also the dominant variant in the U.K. Various subtypes of B.1.617 exist. 

The predominance of B.1.617 in the U.K. underscores its potential to outcompete against B.1.1.7, the so-called “U.K. strain” that became dominant in …

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COVID-19 treatments will continue to lift pharma sector, according to Moody’s

Photo by Anna Shvets from Pexels

The pandemic has eased throughout much of the world. But demand for COVID-19 vaccines and treatments continues to be brisk, according to ratings agency Moody’s. In general, the pandemic will contribute to the pharmaceutical industry’s projected EBITDA growth rate of 4% to 6% over the coming 12 to 18 months, the firm concluded.

While a significant number of vaccines and antivirals are already in use, more will likely win regulatory authorization in the coming months. But the volume of future COVID-19 therapy sales will hinge upon “how the pandemic evolves,” the Moody’s report acknowledged. 

Other factors driving growth include growing healthcare use as countries such as the U.S. continue to lift COVID-19 restrictions. 

Oncology, one of the most rapidly growing pharma areas, is likely to continue its growth trajectory. Moody’s expects immuno-onco…

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Preliminary data point to possible link between myocarditis and mRNA COVID-19 vaccines

Image courtesy of Wikipedia

The theme of myocarditis and pericarditis following mRNA vaccination emerged in today’s Vaccines and Related Biological Products Advisory Committee meeting, which reviewed preliminary safety data of Pfizer-BioNTech vaccine in children aged 12 to 15. The risk, however, appears to be small.

As of May 31, there were 116 reports of myocarditis or pericarditis after the first dose of Pfizer-BioNTech vaccine. There were 100 for the first dose of Moderna vaccine. The problem, however, appears to be more common after the second dose. The government has collected 372 reports of myocarditis or pericarditis after the second dose of Pfizer-BioNTech vaccine and 201 for the Moderna vaccine.

Early data suggests a connection between the mRNA vaccines and myocarditis and pericarditis. Out of 2.3 million doses administered to 16-to-17-year-olds, the VAERS database lists 79 cases of myocardit…

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Biden to promise world 500 million COVID-19 vaccine doses

Pfizer-BioNTech vaccine image courtesy of Wikipedia

President Joe Biden has struck a deal with Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) to provide 500 million COVID-19 vaccine doses to roughly 100 countries over two years.

Biden will announce the plan in the near future at an appearance with Pfizer CEO Dr. Albert Bourla, according to a report from The New York Times.

As COVID-19 cases in the U.S. continue to fall, Biden has faced growing pressure to provide vaccine doses to regions continuing to battle surges in infections.

When boarding Air Force One, Biden confirmed that his administration was making progress with its global vaccine strategy. While hinting at a forthcoming news announcement, he did not offer further information.

Biden has promised to provide 80 million vaccine doses by the end of June.

The U.S. will pay for the COVID-19 doses at cost, according to The New York…

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The top pharma stories of early 2021

Image courtesy of Nataliya Vaitkevich via Pexels.

COVID-19 vaccines dominated pharma industry news during the first half of this year.

It’s little wonder, too, since vaccines are the best hope to return the world to some kind of post-pandemic “normal.”

As with any new medical treatments — especially ones authorized amid an emergency — there have been questions about side effects. Drug Discovery & Development delved into what experts and scientific studies are saying. The overall conclusion is clear: While reactogenicity is a valid concern, the benefits of COVID-19 vaccines greatly outweigh the risks for the vast majority of patients.

Here are eight stories of our stories that delved into potential COVID-19 vaccine side effects:

Dizziness among common COVID-19 vaccine side effects Tinnitus reports grow amid COVID-19 vaccinations Moderna COVID-19 vaccine might cause facial swelling for p…
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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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AstraZeneca could enlist Catalent to produce COVID-19 vaccines

After stopping the production of its COVID-19 vaccine at an Emergent Biosolutions facility in Baltimore, AstraZeneca (LON:AZN) is in negotiations with Catalent (NYSE:CTLT) to shift production to one of its plants in nearby Harmans, Md.

FDA has yet to authorize the AstraZeneca COVID-19 vaccine, although it has won full approval in Australia and Brazil and has received emergency use authorization (EUA) in 168 other countries.

As a majority of U.S. citizens have already received at least one COVID-19 vaccine dose, officials at AstraZeneca are reportedly mulling the option of pursuing full approval of its vaccine instead of EUA, according to The Wall Street Journal.

The U.S. government required Emergent Biosolutions to halt production of the AstraZeneca vaccine after a production error forced Emergent to discard 15 million COVID-19 vaccine doses. Emergent intended to produce AstraZeneca’s and Johnson & Johnson’s adenovirus-vectored vaccines in the same f…

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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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