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,…
GSK’s RSV vaccine candidate for older adults wins priority review from FDA
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)…
AstraZeneca’s Vaxzevria COVID-19 vaccine wins full authorization in Europe
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 reports positive data from RSV vaccine candidate trial
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 wins EU nod for RSV vaccine marketing authorization application
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…
And the most innovative biotechnology and pharma products are…
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…
Regular exercise could bolster the efficacy of COVID-19 vaccination
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 mulls boosting COVID-19 vaccine price to $110 or more per dose
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…
Multiple COVID-19 vaccine doses associated with lower symptom burden
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…
Pfizer shares preliminary findings on omicron-adapted bivalent COVID-19 booster
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…
FDA clears Moderna and Pfizer-BioNTech bivalent COVID-19 boosters in children
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.…
Intranasal version of AstraZeneca’s ChAdOx1 COVID-19 vaccine flunks trial
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.…
COVID-19 drives U.S. life expectancy to 1996 levels
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,…
Real-world data begin to emerge for the Jynneos vaccine in monkeypox outbreak
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…
Pfizer shares top-line data from pivotal study of pentavalent meningococcal vaccine in adolescents
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…
Pfizer launches Phase 3 mRNA flu vaccine study
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)…
Inhaled COVID-19 vaccines making inroads in China, India and Russia
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.…
Pfizer’s group B streptococcus vaccine candidate wins Breakthrough Therapy Designation from FDA
FDA has granted Pfizer’s (NYSE:PFE) investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, Breakthrough Therapy Designation. The designation covers active immunization of mothers during pregnancy to confer protection against invasive GBS disease in newborns and young infants. GBS disease can result in lifelong neurologic impairments or death, according to a 2019 article in…
Two new SARS-CoV-2 antibodies could neutralize COVID-19 strains with high efficacy
Researchers at Tel Aviv University have identified two monoclonal antibodies that are broadly effective against SARS-CoV-2 variants. The researchers investigated the activity of nine anti-SARS-CoV-2 monoclonal antibodies (mAbs) against several variants of concern, including alpha, beta, gamma, delta and omicron. The scientists at the Tel Aviv University’s Sackler Faculty of Medicine suspect that the antibodies…
WHO decision clears path for GSK’s Mosquirix malaria vaccine
The World Health Organization (WHO) has awarded prequalification to GSK’s (LSE/NYSE:GSK) Mosquirix. The move marks the first time that a malaria vaccine has won prequalification. The WHO decision regarding the Mosquirix malaria vaccine is a prerequisite for United Nations (UN) agencies like UNICEF to procure the vaccine in regions with moderate to high P. falciparum malaria transmission. Malaria…
Bavarian Nordic launches Phase 3 clinical study of COVID-19 booster candidate
Bavarian Nordic (OMX:BAVA) has dosed the first subject in a Phase 3 clinical study of the COVID-19 vaccine candidate ABNCoV2. The study will test whether ABNCoV2 is non-inferior to Comirnaty from Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) in terms of neutralizing antibodies it produces against the original strain of SARS-CoV-2. Secondary endpoints in the study will…
The most common monkeypox vaccine side effects
The Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA), the most widely used vaccine to protect against monkeypox, tends to have generally mild side effects according to clinical trial data. It is also clear that the Jynneos vaccine can help reduce the severity of monkeypox infections. Researchers are uncertain, however, about how the vaccine’s potential to…
FDA greenlights bivalent COVID-19 boosters from Pfizer and Moderna
FDA has authorized bivalent COVID-19 boosters from Moderna (Nasdaq:MRNA) and Pfizer/BioNTech (NYSE:PFE/Nasdaq:BNTX). The FDA has authorized the updated Moderna vaccine as a single booster dose in individuals at least 18 years old. In addition, the agency authorized the Pfizer/BioNTech vaccine for those at least 12 years old. Individuals in those age groups who have waited…
FDA reportedly will soon authorize updated COVID-19 boosters
The FDA is on the verge of authorizing updated COVID-19 boosters without the benefit of Phase 3 clinical trial data, according to media reports. The bivalent boosters, based on the omicron sublineages BA.4 and BA.5 and the original form of SARS-CoV-2, could be available soon after Labor Day. To authorize the omicron-specific COVID-COVID-19 boosters, FDA…
Moderna says Pfizer-BioNTech COVID vaccine infringed its patents
Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer (NYSE:PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq:BNTX) over patent infringement in U.S. and German courts. Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany. The suits could…