Infectious Disease

In October, Pfizer (NYSE:PFE) signaled its plans to raise its COVID-19 vaccine price to roughly $110 to $130 per dose. The new price would go effect after the U.S. government’s purchase program for the vaccine expires, said Angela Lukin, Pfizer’s global primary care and U.S. president. Senator Warren and Senator-elect Welch asked Pfizer CEO Albert…

The pandemic has complicated the treatment of cold agglutinin disease (CAD), a rare autoimmune hemolytic anemia accounting for roughly 20% of all autoimmune hemolytic anemia. CAD affects older adults primarily. The anti-CD20 therapies commonly used off-label to treat the disease also increase the risk of serious COVID-19 infections and interfere with the immune response to COVID-19…

Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5. The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6…

Pfizer (NYSE:PFE) and vaccine firm Valneva (Nasdaq:VALN; Euronext Paris:VLA) have released six-month antibody persistence data for children and adults receiving their Lyme disease vaccine candidate.  In the Phase 2 VLA15-221 study, individuals received either three doses of the vaccine (at months 0, 2 and 6) or two doses (at months 0 and 6).  The study…

Antimicrobial resistance (AMR) is a growing global threat that, without intervention, could lead to as many as 10 million deaths annually by 2050.1 Unfortunately, the development of new antibiotics that could combat this risk is a significantly underinvested area, with few new treatments in the pipeline, and other therapy areas currently offering more attractive opportunities for…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have announced that their omicron BA.4/BA.5-adapted bivalent booster fared well against novel omicron variants in neutralizing antibody detection tests. The company published the results from the bivalent booster tests against the BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1 subvariants on the preprint server BioRxiv. One month after administering a fourth vaccine dose, the…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have begun a Phase 1 study to investigate the next-generation BNT162b4 COVID-19 vaccine candidate that could potentially result in a stronger and more durable immune response. Known as BNT162b4, the vaccine candidate has a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are conserved across various variants. The…

The European Commission has approved the VidPrevtyn Beta COVID-19 vaccine as a booster for individuals who are at least 18. The vaccine is the first next-gen protein-based adjuvanted COVID-19 booster to win European approval. Sanofi (Nasdaq:SNY) developed the vaccine based on the beta variant using GSK’s (NYSE:GSK) pandemic adjuvant. After announcing the news, Sanofi shares…

The antiviral nirmatrelvir in Paxlovid reduced the likelihood of people experiencing long-term symptoms after a COVID-19 infection, according to a recent preprint. Individuals who took Paxlovid within five days after infection were 26% less likely to have symptoms of long COVID 90 days after infection.  The drug was associated with a reduced risk of long-COVID symptoms,…

On the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults. The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA)…

Although not available in the U.S., AstraZeneca’s (LON:AZN) Vaxzevria COVID-19 vaccine has won full marketing authorization in the European Union. European authorities initially granted conditional marketing authorization to the vaccine for individuals at least 18 years old in early 2021. However, in April, the European Medicines Agency (EMA) noted that the vaccine had a possible link to…

Pfizer (NYSE:PFE) today announced positive topline data from a Phase 3 clinical trial for its bivalent respiratory syncytial virus (RSV) prefusion vaccine candidate. The MATISSE (Maternal Immunization Study for Safety and Efficacy) study investigates Pfizer’s RSVpreF vaccine candidate. It observed the vaccine when administered to pregnant participants to help protect their infants from RSV disease…

GSK (LSE/NYSE:GSK) has won validation of the marketing authorization application from the European Medicines Agency (EMA) for its respiratory syncytial virus (RSV) vaccine candidate. GSK is pursuing authorization to use the vaccine annually in older adults. European regulators will likely announce a final regulatory decision in the third quarter of 2023. The vaccine candidate would…

The Galien Foundation has selected Regeneron’s (Nasdaq:REGN) Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the best biotechnology product of 2022 and Amgen’s (Nasdaq:AMGN) Lumakras as the best pharmaceutical agent. The organization announced the news last week as part of the Prix Galien USA 2022 awards series in a ceremony in New York City. The antibody cocktail Inmazeb…

Recent research published in BMJ found that regular physical exercise appeared to bolster the efficacy of Janssen’s (NYSE:JNJ) Ad26.COV2.S COVID-19 vaccine. While the vaccine was 60.0% effective against hospitalization in individuals with a low activity level, efficacy climbed to 85.8% for those with a high activity level. Efficacy was 72.1% for individuals in the moderate activity group.…

Pfizer (NYSE:PFE) signaled its intent to increase its COVID-19 vaccine price to roughly $110 to $130 per dose after the U.S. government’s purchase program for the vaccine expires, according to Angela Lukin, Pfizer’s global primary care and U.S. president. The COVID-19 vaccine price hike would pertain to patients 12 and older. The company could revise…

A study of essential and frontline workers infected with COVID-19 found that recent vaccination was associated with a variety of benefits. In particular, the workers who had received two or three mRNA COVID-19 vaccine doses had lower viral loads than the unvaccinated. They also had fewer fever and chill symptoms and were less likely to…

Early data from a Pfizer-BioNTech (NYSE:PFE/Nasdaq:BNTX) Phase 2/3 study (NCT05472038) indicate that their updated omicron BA.4/BA.5-adapted bivalent COVID-19 booster works as intended.  After drawing sera from booster recipients seven days after administration, investigators concluded that a single 30-µg booster dose increased omicron BA.4/BA.5 neutralizing antibody levels. In addition, they note that the updated vaccine potentially…

The FDA has amended emergency use authorizations (EUAs) for the bivalent COVID-19 vaccine boosters from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE) to allow their use in children at least five years old. FDA authorized a single dose of either bivalent vaccine in younger age groups at least two months after completion of primary or booster vaccination.…

Experts have theorized that mucosal vaccines, which could be administered nasally, orally or transdermally, could alter the trajectory of the pandemic. But a recent setback involving an intranasal version of AstraZeneca’s ChAdOx1 nCoV-19 COVID-19 has dampened those hopes.  A Phase 1 study published on Lancet’s eBioMedicine found that intranasal vaccination was detectable in a minority of participants.…

A CDC research paper published in JAMA notes that U.S. life expectancy dropped to about 73 for men and 79 for women between 2019 and 2021.  That constitutes a 3-year reduction for men and a 2.3-year dip for women, according to provisional estimates from the National Center for Health Statistics. For the sake of comparison,…

Until recently, CDC had warned that it remained uncertain how effective the Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA) and the ACAM2000 vaccine from Emergent BioSolutions (NYSE:EBS) were at guarding against the current monkeypox outbreak.  The CDC, however, has begun to release data related to the former vaccine. The agency found unvaccinated patients were approximately 14…

Aiming to extend its vaccine empire, Pfizer (NYSE:PFE) has announced that its meningococcal vaccine (MenABCWY) candidate met primary and secondary endpoints in a Phase 3 study. The NCT04440163 study tested the vaccine in healthy individuals between the ages of 10 and 25. The vaccine candidate demonstrated non-inferiority to the licensed vaccines Trumenba and Menveo for…

Big Pharma behemoth Pfizer (NYSE: PFE) has dosed the first participants in a pivotal Phase 3 clinical trial to test its quadrivalent modified RNA (modRNA) influenza vaccine candidate.  The mRNA flu vaccine study will enroll roughly 25,000 healthy U.S. adults. Pfizer is not the only company to develop an mRNA flu vaccine. In December, Moderna (Nasdaq:MRNA)…

The idea of inhalable COVID-19 vaccines may not be new, but, until recently, no country had approved a COVID-19 vaccine with an alternative delivery route. That changed on March 31, 2022, when Russia greenlit the Galaleya Institute’s Sputnik V inhaled vaccine. The country authorized a similar nasal-drop-based vaccine known as Salnavac on July 4, 2022.…