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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…

Adamis Pharmaceuticals’ Tempol shows promise against SARS-CoV-2 in preclinical research

The investigational drug Tempol from Adamis Pharmaceuticals Corp. (NSDQ:ADMP) could be a potent oral antiviral treatment for COVID-19 based on cell culture research, according to scientists at the National Institutes of Health (NIH).

The positive research news caused Adamis Pharmaceuticals’ stock to jump 61% from $0.69 to $1.13 today. The quick jump in its stock valuation triggered a trading halt.

Tempol belongs to a growing class of anti-COVID-19 drugs that aim to stop viral replication.

Pfizer (NYSE:PFE) is also developing a similar potential COVID-19 treatment known as PF-07321332 that is a protease inhibitor. That investigational drug binds to a viral enzyme known as protease to stop viral replication.

Remdesivir, the subcutaneous injectable drug from Gilead Sciences (NSDQ:GILD) that won FDA approval on October 22, 2020, binds to the RNA polymerase and protease of SARS-CoV-2.

Tempol relies on a different mode of action. The drug in…

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…

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…

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.

10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Here are the 10 companies that came in on top:

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

10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Here are the 10 companies that came in on top.

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

And browse data on all the Pharma 50 companies here.

10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Below are the 10 companies that came in on top. (And browse data on all the Pharma 50 companies here.)

1. Sage Therapeutics

Glassdoor rating: 4.4/5 83% would recommend to a friend

Pros: Workers at Sage Therapeutics applauded the company’s work-life balance and culture. Just under three-quarters (74%) had a positive business outlook for the firm. One recent reviewer found meaning in “doing the toughest job in the world by developing CNS drugs.” The company’s brain health p…

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…

WHO: All countries should vaccinate at least 10% of their people against COVID-19 by September

[Image from Wikimedia Commons/Russell Watkins/DFID]

World Health Organization (WHO) director-general Dr. Tedros Adhanom Ghebreyesus announced the organization’s aims for global COVID-19 vaccinations.

During an address to the annual World Health Assembly today, Ghebreyesus called for all countries to have at least 10% of their populations vaccinated by September and at least 30% by the end of 2021.

In low- and middle-income countries, about 250 million more people would need to get vaccinated if the world were to reach the September threshold, with Ghebreyesus saying all healthcare workers and the most at-risk groups should have priority.

“This is crucial to stop severe disease and death, keep our health workers safe and reopen our societies and economies,” Ghebreyesus said. “We must be very clear: the pandemic is not over, and it will not be over until and unless transmission is controlled…

Merck facing off with Pfizer with pneumococcal vaccines

Pfizer’s (NSE:PFE) pneumococcal 13-valent conjugate vaccine Prevnar 13 brought in $5.85 billion last year, but Merck (NYSE:MRK) is hoping to increase its presence in the market with its investigational 15-valent pneumococcal conjugate vaccine.

Although Merck has a pneumococcal vaccine on the market known as Pneumovax 23, its sales were $1.1 billion last year. While technically a blockbuster, Pneumovax 23’s sales were only about one-fifth of Prevnar 13’s.

Merck announced that its V114 investigational 15-valent pneumococcal conjugate vaccine hit its primary immunogenicity and safety endpoints in two trials.

The company says the data potentially supports the use of the vaccine in healthy infants who have previously started immunization with the 13-valent pneumococcal conjugate vaccine, who are vaccine-naïve or previously had received lower valency pediatric pneumococcal conjugate vaccines.

“At Merck, our goal is to expand coverage to new serotypes no…

50 of 2020’s best-selling pharmaceuticals

Drug sales in 2020 proved more resilient than many experts anticipated in the early days of the pandemic. Still, the impact on many injectable drugs was tangible in the first half of the year as hospitals initially dissuaded patients from seeking in-person treatment. But sales were generally strong for the full year.

AbbVie’s injectable biologic Humira brought in nearly $20 billion in sales in 2020, with $16 billion in the U.S. alone. A year earlier, sales of the drug were $19.17 billion.

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