Infectious Disease

Roche announced today that it received FDA emergency use authorization (EUA) for intravenous Actemra/RoActemra in treating COVID-19. Basel, Switzerland-based Roche’s Actemra/RoActemra (tocilizumab) drug received authorization to treat COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or…

The pace of COVID-19 vaccination in the U.S. continues to fall. Today, the U.S. administered about 600,000 COVID-19 vaccine doses, which is far fewer than two months ago. At the mid-April peak, healthcare workers administered more than 3 million COVID-19 vaccine doses. The pace of vaccination fell steadily from that time to early June before…

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…

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39.  The conditions appear to be more common in males.  The FDA warning…

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,…

Moderna (NSDQ:MRNA) has announced that the European Commission has reserved an additional 150 million doses of its COVID-19 vaccine for delivery in 2022. To date, the European Commission has reserved 460 million Moderna vaccine doses.  The new deal gives the European Commission the ability to purchase new COVID-19 vaccines.  The company is currently testing various…

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…

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…

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…

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…

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.…

Novavax (NSDQ:NVAX) announced today that its COVID-19 vaccine demonstrated 90.4% efficacy in protecting against COVID-19. Gaithersburg, Md.–based Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine demonstrated 100% protection against moderate and severe disease, with 90.4% efficacy overall as it met the primary endpoint in the Prevent-19 pivotal Phase 3 trial. According to a news release, the study…

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…

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…

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…

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…

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…

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200…

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 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…

  Moderna (Nasdaq:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older. Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move…

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…

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…

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…

Researchers at the University of Texas at Austin are touting chemical probes designed to help identify an enzyme produced by bacterias. The team at UT Austin developed the probes to identify the enzyme produced by some types of E. coli and pneumococcal bacteria that are resistant to treatment because of their ability to break down…