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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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FDA approves vaccine Vaxchora to prevent cholera for travelers


06/10/2016 04:22 PM EDT
The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.

June 10, 2016

Release

The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.

Cholera, a disease caused by Vibrio cholerae bacteria, is acquired by ingesting contaminated water or food and causes a watery diarrhea that can range from mild to extremely severe. Often the infection is mild; however, severe cholera is characterized by profuse diarrhea and vomiting, leading to dehydration. It is potentially life threatening if treatment with antibiotics and fluid replacement is not initiated promptly. According to the World Health Organization, serogroup O1 is the predominant cause of cholera globally.

“The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by the Centers for Disease Control and Prevention for travelers to cholera-affected regions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

While cholera is rare in the U.S., travelers to parts of the world with inadequate water and sewage treatment and poor sanitation are at risk for infection. Travelers to cholera-affected areas have relied on preventive strategies recommended by the CDC to protect themselves against cholera, including safe food and water practices and frequent hand washing.

Vaxchora is a live, weakened vaccine that is taken as a single, oral liquid dose of approximately three fluid ounces at least 10 days before travel to a cholera-affected area.

Vaxchora’s efficacy was demonstrated in a randomized, placebo-controlled human challenge study of 197 U.S. volunteers from 18 through 45 years of age. Of the 197 volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae, the bacterium that causes cholera. Vaxchora efficacy was 90 percent among those challenged 10 days after vaccination and 80 percent among those challenged three months after vaccination.  The study included provisions for administration of antibiotics and fluid replacement in symptomatic participants. To prevent transmission of cholera into the community, the study included provisions for administration of antibiotics to participants not developing symptoms.

Two placebo-controlled studies to assess the immune system’s response to the vaccine were also conducted in the U.S. and Australia in adults 18 through 64 years of age. In the 18 through 45 year age group, 93 percent of Vaxchora recipients produced antibodies indicative of protection against cholera. In the 46 through 64 years age group, 90 percent produced antibodies indicative of protection against cholera. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas.

The safety of Vaxchora was evaluated in adults 18 through 64 years of age in four randomized, placebo-controlled, multicenter clinical trials; 3,235 study participants received Vaxchora and 562 received a placebo. The most common adverse reactions reported by Vaxchora recipients were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea.

The FDA granted the Vaxchora application fast track designation and priority review status. These are distinct programs intended to facilitate and expedite the development and review of medical products that address a serious or life-threatening condition. In addition, the FDA awarded the manufacturer of Vaxchora a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.

Vaxchora is manufactured by PaxVax Bermuda Ltd., located in Hamilton, Bermuda.

Company PaxVax Inc.
Description Live attenuated vaccine against Vibrio cholerae
Molecular Target
Mechanism of Action Vaccine
Therapeutic Modality Preventive vaccine: Viral vaccine
Latest Stage of Development Registration
Standard Indication Cholera
Indication Details Prevent cholera infection; Treat cholera
Regulatory Designation U.S. – Fast Track (Prevent cholera infection);
U.S. – Priority Review (Prevent cholera infection)

FDA Approves Vaxchora, PaxVax’s Single-Dose Oral Cholera Vaccine

Vaxchora™ is the only approved vaccine in the U.S. for protection against cholera

June 10, 2016 04:32 PM Eastern Daylight Time

REDWOOD CITY, Calif.—-PaxVax, today announced that it has received marketing approval from the United States (U.S.) Food and Drug Administration (FDA) for Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Vaxchora is the only vaccine available in the U.S. for protection against cholera and the only single-dose vaccine for cholera currently licensed anywhere in the world.

FDA Approves Vaxchora, PaxVax’s Single-Dose Oral Cholera Vaccine

“FDA approval of a new vaccine for a disease for which there has been no vaccine available is an extremely rare event. The approval of Vaxchora is an important milestone for PaxVax and we are proud to provide the only vaccine against cholera available in the U.S.,” said Nima Farzan, Chief Executive Officer and President of PaxVax. “We worked closely with the FDA on the development of Vaxchora and credit the agency’s priority review program for accelerating the availability of this novel vaccine. In line with our social mission, we have also begun development programs focused on bringing this vaccine to additional populations such as children and people living in countries affected by cholera.”

“As more U.S. residents travel globally, there is greater risk of exposure to diseases like cholera,” added Lisa Danzig, M.D., Vice President, Clinical Development and Medical Affairs. “Cholera is an underestimated disease that is found in many popular global travel destinations and is thought to be underreported in travelers. Preventative measures such as food and water precautions can be challenging to follow effectively and until now, U.S. travelers have not had access to a vaccine to help protect against this potentially deadly pathogen.”

Cholera is an acute intestinal diarrheal infection acquired by ingesting contaminated water and food. Annually, millions of people around the world are impacted by this extremely virulent disease1 which can cause death in less than 24 hours if left untreated2. More than 80 percent of reported U.S. cases3 are associated with travel to one of the 69 cholera-endemic countries4 in Africa, Asia and the Caribbean. A recent report from the Centers for Disease Prevention and Control suggests that the true number of cholera cases in the U.S. is at least 30 times higher than observed by national surveillance systems5. The currently recommended intervention to prevent cholera infection is the avoidance of contaminated water and food, but studies have shown that 98 percent of travelers do not comply with these precautions when travelling6.

“This important FDA decision is the culmination of years of dedicated work by many researchers,” said Myron M. Levine, MD, DTPH, the Simon and Bessie Grollman Distinguished Professor at the University of Maryland School of Medicine (UM SOM). “For travelers to the many parts of the world where cholera transmission is occurring and poses a potential risk, this vaccine helps protect them from this disease. It is a wonderful example of how public-private partnerships can develop medicines from bench to bedside.” Dr. Levine is co-inventor of the vaccine, along with James B. Kaper, PhD, Chairman of the UM SOM Department of Microbiology and Immunology. In addition, the Center for Vaccine Development at UM SOM worked closely with PaxVax during the development of Vaxchora.

The attenuated cholera vaccine strain used in Vaxchora is CVD 103-HgR, which was in-licensed from the Center for Vaccine Development at UM SOM in 2010. Vaxchora is expected to be commercially available in Q3 2016. Vaxchora will be distributed through PaxVax’s U.S. marketing and sales organization, which currently commercializes Vivotif®, an FDA-approved oral typhoid fever vaccine.

About Vaxchora (Cholera Vaccine, Live, Oral)

Vaxchora is an oral vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. Vaxchora is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas or in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Vaxchora has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

The FDA approval of Vaxchora is based on positive results from a 10 and 90-day cholera challenge trial, as well as two safety and immunogenicity trials in healthy adults that demonstrated efficacy of more than 90 percent at 10 days and 79 percent at 3 months post vaccination7. The most common adverse reactions were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea. More than 3,000 participants were enrolled in the Phase 3 clinical trial program that evaluated Vaxchora at sites in Australia and the United States.

For the full Prescribing Information, please visit www.vaxchora.com.

Young man drinking contaminated water. Close-up of vibrio cholerae bacteria.
A bacterial disease causing severe diarrhoea and dehydration, usually spread in water

About PaxVax

PaxVax develops, manufactures and commercializes innovative specialty vaccines against infectious diseases for traditionally overlooked markets such as travel. PaxVax has licensed vaccines for typhoid fever (Vivotif) and cholera (Vaxchora), and vaccines at various stages of research and clinical development for adenovirus, anthrax, hepatitis A, HIV, and zika. As part of its social mission, PaxVax is also working to make its vaccines available to broader populations most affected by these diseases. PaxVax is headquartered in Redwood City, California and maintains research and development and Good Manufacturing Practice (GMP) facilities in San Diego, California and Bern, Switzerland and other operations in Bermuda and Europe. More information is available at www.PaxVax.com.

References:

1 Centers for Disease Control and Prevention. Cholera: General Information. November 2014. http://www.cdc.gov/cholera/general. Accessed June 2016.

2 World Health Organization website. Cholera Fact Sheet. July 2015. http://www.who.int/mediacentre/factsheets/fs107/en/. Accessed June 2016.

3 Loharikar A et al. Cholera in the United States, 2001-2011: a reflection of patterns of global epidemiology and travel. Epidemiol Infect. 2015;143(4):695-703. doi:10.1017/S0950268814001186.

4 Ali M et al. Updated global burden of cholera in endemic countries. PLoS Negl Trop Dis. 2015; 9: e0003832 doi: 10.1371/journal.pntd.0003832.

5 Scallan E et al. Foodborne Illness Acquired in the United States –Major Pathogens. Emerg Infect Dis. 2011. http://dx.doi.org/10.3201/eid1701.P11101.

6 Kozicki M et al. Boil it, cook it, peel it or forget it’: does this rule prevent travellers’ diarrhoea?. Int J. Epidemiol. 1985; 14(1):169-72.

7 Chen WH et al. Single-Dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection with Vibrio cholerae O1 El Tor. Clinical Infectious Diseases 2016. 62 (11) 1329-1335. doi: 10.1093/cid/ciw145.

Contacts

PaxVax Inc.
Colin Sanford, 415-870-9188
colin.sanford@W2comm.com

/////FDA.  vaccine,  Vaxchora, choleram  travelers, PaxVax Bermuda Ltd.,Hamilton, Bermuda.

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Russian Ebola Vaccine in Preclinical Trials


 

Anna Popova, Head of the Federal Service for Supervision of Consumer Protection and Welfare (Rospotrebnadzor)

MOSCOW, August 5 (RIA Novosti) – A Russian vaccine against Ebola hemorrhagic fever is now undergoing preclinical tests, Russian consumer rights watchdog, Rospotrebnadzor, head Anna Popova told journalists.

Russian Ebola Vaccine in Preclinical Trials

RIA Novosti

As of today, it is in a stage of preclinical drug trials. The works are intensified now,” Popova said. She added that there are currently no licensed drugs …

 

see link

 

http://en.ria.ru/russia/20140805/191739156/Russian-Ebola-Vaccine-in-Preclinical-Trials.html

 

 

 

 

 

Novavax announces positive preclinical data for vaccine against influenza


 
Influenza

Novavax announces positive preclinical data for vaccine against influenza

Novavax has announced positive preclinical results for its virus-like particle (VLP) vaccine candidate against A (H7N9) influenza.

The study examined the immunogenicity, the ability to provoke an immune response, and efficacy of two doses of its A(H7N9) VLP vaccine candidate against a lethal wild-type challenge mouse model.

There were three control groups, including Novavax’ non-homologous A(H7N3) VLP vaccine candidate, its A(H5N1) VLP vaccine candidate, and a placebo. All vaccine candidates were administered with or without Iscomatrix, a saponin-based adjuvant.

read all at

http://www.pharmaceutical-technology.com/news/newsnovavax-announces-positive-preclinical-data-for-vaccine-against-influenza?WT.mc_id=DN_News

 

 

 

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Serum Institute of India acquires rights to TB vaccine


Serum Institute of India acquires rights to TB vaccine

Serum Institute of India, a Pune-based manufacturer of vaccines, is planning on taking a promising vaccine – originally developed in Germany – and introducing it into the clinic. Studies have shown that the new vaccine is more effective and better tolerated than currently available options.

By signing a contract with Hannover-based Vakzine Projekt Management (VPM), Serum has secured the licence to the various patents and technologies related to the…

Click here to read more

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HPV Vaccine Halves Infection Rate in Teen Girls


A vaccine against a cervical cancer virus has cut infections in teen girls by half, according to a study released.

read all at

http://www.dddmag.com/news/2013/06/hpv-vaccine-halves-infection-rate-teen-girls?et_cid=3324641&et_rid=523035093&type=cta

A vaccine against a cervical cancer virus has cut infections in teen girls by half, according to a study released. The study confirms research done before the HPV vaccine came on the market in 2006. But this is the first evidence of how well it works now that it is in general use.

Cervical Cancer Awareness Month-serviks-abnormal-image7

Researchers Begin Shigella Vaccine Trial , WRSs2 and WRSs3


FEB2013

PHASE 1 Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines WRSs2 and WRSs3

Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of single doses of S. sonnei. Enroll serial groups up to 90 subjects. Evaluate safety and tolerance of WRSs2 by monitoring presence and severity of clinical signs and symptoms, evaluate the immune response in blood and stool following ingestion of WRSs2

http://clinicaltrials.gov/show/NCT01336699

Shigellosis is one of those nasty bacterial diseases that follows the cringeworthy fecal-oral route to infect humans and other primates. Mild cases bring stomachaches; the severe end includes cramping, vomiting, fever, diarrhea, and it generally only gets more disgusting from there. While the disease can occur all over the world—estimates suggest ninety million cases of Shigellosis dysentery each year—the greatest mortality occurs in the third world. Hoping to stem transmission, or, at least, minimize the damage it causes, the World Health Organization has long called for a vaccine to stop Shigella infection.

And, today, scientists are one step closer. The National Institutes of Health announced that two Shigella vaccine have entered early-stage human clinical trials:

Researchers have launched an early-stage human clinical trial of two related candidate vaccines to prevent infection with Shigella, bacteria that are a significant cause of diarrheal illness, particularly among children. The Phase 1 clinical trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will evaluate the vaccines for safety and their ability to induce immune responses among 90 healthy adults ages 18 to 45 years. The trial is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the eight NIAID-funded Vaccine and Treatment Evaluation Units in the United States.

Researchers have launched an early-stage human clinical trial of two related candidate vaccines to prevent infection with Shigella, bacteria that are a significant cause of diarrheal illness, particularly among children. The Phase I clinical trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will evaluate the vaccines for safety and their ability to induce immune responses among 90 healthy adults ages 18 to 45 years. The trial is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the eight NIAID-funded Vaccine and Treatment Evaluation Units in the United States ….

…. Led by principal investigator Robert W. Frenck, Jr., M.D., director of clinical medicine at Cincinnati Children’s, the new clinical trial will evaluate two related candidate vaccines, known as WRSs2 and WRSs3, which have been found to be safe and effective when tested in guinea pigs and nonhuman primates. Both target Shigella sonnei, one of the bacteria’s four subtypes and the cause of most shigellosis outbreaks in developed and newly industrialized countries. Though neither candidate vaccine has been tested in humans, a precursor to both, known as WRSs1, was found to be safe and generated an immune response in small human trials in the United States and Israel. This early work was supported by NIAID, the U.S. Department of Defense and the Walter Reed Army Institute of Research. All three versions of the vaccine were developed by researchers at the Walter Reed institute.

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