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No connection between Pfizer COVID-19 vaccine and Bell’s palsy, study finds

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A case-control study in Israel found no association between recent vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNtech (NSDQ:BNTX) and facial nerve (Bell’s) palsy. JAMA published the study.

Clinical trials for Pfizer-BioNtech and Moderna COVID-19 vaccines revealed numerical imbalances regarding peripheral facial nerve (Bell’s) palsy. In the former Phase 3 trial, which involved approximately 38,000 patients, four patients in the vaccine group developed Bell’s palsy while none in the placebo group did. FDA concluded in a briefing document that the four cases did not rise above the expected rate in the general population but recommended that health officials monitor mRNA vaccine recipients for Bell’s palsy.

To analyze whether the BNT162b2 vaccine resulted in an …

RedHill Biopharma announces positive data for oral COVID-19 drug

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced positive results from a Phase 2 U.S. study involving its opaganib in hospitalized COVID-19 patients with pneumonia.

The study indicated that opaganib reduced the need for supplemental oxygen therapy and an earlier hospital discharge. RedHill also concluded that the drug was well-tolerated based on the placebo-controlled Phase 2 study, which involved 40 patients in the U.S.

The experimental drug inhibits sphingosine kinase-2 (SK2), an enzyme that plays a role in inflammation and replication of some viruses. Opaganib thus has dual antiviral and anti-inflammatory modes of action.

A total of 50% of opaganib recipients could breathe without ventilator support within 14 days of treatment compared to 22% of people in the placebo group.

Some 86.4% of patients receiving opaganib were able to leave the hospital within 14 days compared with 55.6% of placebo recipients.

The study anticipates that th…

Could the controversial drug ivermectin save lives?

[Photo by Fusion Medical Animation on Unsplash]

The antiparasitic drug ivermectin holds promise as a COVID-19 treatment, according to a new study published in the American Journal of Therapeutics. The study authors conclude that ivermectin could reduce the risk of COVID-19-related death with moderate-certainty evidence. “Using ivermectin early in the clinical course may reduce numbers progressing to severe disease,” they conclude, adding that the drug is “likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

The meta-analysis analyzed databases up to April 2021, drawing from 24 randomized controlled trials with 3,406 patients.

Another study published in Lancet found a concentration-dependent antiviral activity of oral high-dose ivermectin in a trial involving 45 patients.

Many experts, however, have voiced skepticism regarding the use of ivermectin as a COVID-19 treatment.…

White House allocates 55M COVID-19 vaccine doses for global distribution

[Photo by Daniel Schludi on Unsplash]The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply.

Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan for the first 25 million doses that the U.S. has begun shipping, with the remaining 55 million doses announced today.

Get the full story at our sister site, Pharmaceutical Processing World.

White House to allocate 55M COVID-19 vaccine doses for global distribution

The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply.

Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan for the first 25 million doses that the U.S. has begun shipping, with the remaining 55 million doses announced today.

According to a news release, the U.S. will share 75% of the 80 million through COVAX and 25% are earmarked to help with surges around the world. The doses are slated to be allocated based on national vaccine plans, prioritizing those most at risk, including healthcare workers.

The allocation plan for the 55 million doses announced today includes 41 million to be shared through COVAX, with 14 million for Latin America and the Caribbean, with doses going to Brazil, Argentina, Brazil, Arge…

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…

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…

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…

Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

President Joe Biden [Image courtesy of the White House]President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

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

Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

[Image courtesy of Biden for President]

President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

The program is a collaboration within the U.S. Department of Health and Human Services (HHS) that includes the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) — and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness …