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Australia COVID-19 vaccine supply limited until August

Australia image from Pixabay.

As the U.S. sees demand plateauing for COVID-19 vaccines, Australia is facing a shortage of both vaccine supplies and healthcare workers.

Australian health officials project that the nation’s vaccination program will face delays from June to July. The slowdown is partly a result of limited shipments of the Pfizer vaccine. Australia expects to receive 1.7 million doses of the vaccine this month and another 2.8 million in July.

Australian officials are also aiming to enlist a greater number of general practitioners to help dispense vaccines later in the summer when supplies are likely to increase.

Like several other countries, Australia has also limited the use of the AstraZeneca (LON:AZN) vaccine over the risk of rare blood clots. Health officials there recently recommended the AstraZeneca vaccine only for adults 60 and older.

Australia’s Chief Medical Office…

Assessing pharma headwinds and tailwinds in mid-2021

Pfizer-BioNTech COVID-19 vaccine. Image courtesy of Wikimedia Commons.

Now that we have passed the year’s midway mark, pharma continues to be in a unique position.

While COVID-19 gave the industry an opportunity for a reputational reset in 2020, the pandemic is now a net positive for the industry, according to the recent Moody’s report, “Solid demand, lift from COVID-19 products continue to drive positive outlook.”

While demand for COVID-19 vaccines has ebbed recently in the U.S., Moody’s projects strong vaccine sales overall for the remainder of 2021. Pfizer (NYSE:PFE) upped their guidance for vaccine sales to $26 billion in their first-quarter earnings report. “Their approach to guidance for revenue is based on contracts that have been signed,” said Michael Levesque, lead author of the report. Thus, any future contracts that Pfizer signs after that guidance update will further expand their guidance …

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…

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…

Moderna vaccine highly effective two weeks after first dose

A study published in JAMA involving healthcare workers found that the first dose of Moderna’s (NSDQ:MRNA) COVID-19 vaccine was highly effective at reducing the risk of COVID-19 infections.

In the study, participants received two doses of the vaccine at the recommended 28-day interval. Clinical effectiveness reached 95% for days 15 through 42 of the study. But constraining the window to days 15 to 28 resulted in similar results.

The findings suggest that the vaccine can rapidly reduce the incidence of vaccine-sensitive SARS-CoV-2 infection in healthcare workers.

Even eight days after administration of the first dose, the vaccine yielded greater than 70% efficacy.

The study authors concluded that their findings were in line with aggregated data for the Pfizer-BioNTech BNT162b2 and Moderna’s mRNA-1273 vaccines.

The 42-day study began on Dec. 22, 2020. It involved 4,028 participants.

A number of healthcare workers have made headlines rec…

Pfizer’s Prevnar 20 vaccine wins FDA approval

Pfizer’s (NSE:PFE) pneumococcal 13-valent conjugate vaccine Prevnar 13 is one of pharma’s bestsellers, earning nearly $6 billion last year.

Now, the company has scored FDA approval for its Prevnar 20 vaccine for adults 18 and older.

The vaccine is the first to offer protection against 20 serotypes of pneumococcal disease that cause the majority of pneumonia and invasive pneumococcal disease. In addition to the capsular polysaccharide conjugates already included in Prevnar 13, the new vaccine adds conjugates for seven different serotypes linked with invasive pneumococcal disease, antibiotic resistance and meningitis.

“With a single injection, Prevnar 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world,” said Kathrin U. Jansen, senior vice president and head of vaccine research and development at Pfizer, in a statement.

Pfizer oversaw Phase 1 and…

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 …

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…

Biden to promise world 500 million COVID-19 vaccine doses

President Joe Biden [Image courtesy of the White House]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.

The two companies today confirmed the news, saying that the U.S. government will purchase at a not-for-profit price 200 million doses in 2021 and 300 million in early 2022. Doses will go to 100 low- and lower-middle-income countries including those in the African Union via the COVAX Facility.

Get the full story on our sister site Pharmaceutical Processing World.

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…

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…

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.

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