Covaxin Phase 2&3 trials to resume in US after USFDA lifts clinical hold

FDA Calls for Fall COVID Boosters To Target Omicron Subvariants

FDA Calls for Fall COVID Boosters , To Target Omicron Subvariants. NBC News reports that on June 30, the Food and Drug Administration asked vaccine makers to modify upcoming booster shots to target subvariants of Omicron. The Omicron subvariants the agency wishes to target are BA.4 and BA.5. Officials have called on vaccine makers Pfizer-BioNTech and Moderna to produce bivalent vaccines, . which are intended to target the original strain of COVID-19 as well as its subvariants. As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection... , Dr. Peter Marks, FDA, via NBC News. ... against circulating and emerging variants to prevent the most severe consequences of COVID-19. , Dr. Peter Marks, FDA, via NBC News. As of the week ending June 25, Omicron subvariants BA.4 and BA.5 were responsible for 52% of all new cases of COVID-19. Per the Centers for Disease Control and Prevention, BA.1, the first variant of Omicron, caused 0% of new cases. Pfizer and Moderna have thus far altered vaccines to target the original strain of COVID-19 and BA.1. which increased the immune response to earlier iterations, though both have waned in their efficacy against BA.4 and BA.5

Pfizer Says Updated COVID-19 Shot Effective Against Omicron

Pfizer Says Updated COVID-19 Shot , Effective Against Omicron. NBC News reports Pfizer announced on June 25 that its updated coronavirus vaccine better targets the omicron variant. Experts say while current vaccines offer ample protection against new variants, . their effectiveness has waned in the age of omicron. The Food and Drug Administration has considered ordering altered vaccines, . hoping a modified recipe could offer more protection when coronavirus surges again this fall and winter. Pfizer says after studying over 1,200 adults who had received three vaccine doses. officials say each of their vaccines showed a substantial increase in omicron-resistant antibodies. Based on these data, we believe we have two very strong omicron- adapted candidates. , statement from Pfizer CEO Albert Bourla, via NBC News. Pfizer's tweaked shot shows a 9 to 11-fold increase in omicron-fighting antibodies. almost 1.5 times higher than the company's initial dose

FDA To Pull Juul E-Cigarettes off US Market

FDA To Pull Juul E-Cigarettes , off US Market. Fox News and other outlets report that the Food and Drug Administration (FDA) is gearing up to order Juul Labs Inc. to remove its e-cigarettes from store shelves in America. Fox News and other outlets report that the Food and Drug Administration (FDA) is gearing up to order Juul Labs Inc. to remove its e-cigarettes from store shelves in America. The announcement is expected to come as data presented by Juul has been under review for nearly two years. . The announcement is expected to come as data presented by Juul has been under review for nearly two years. . Fox News reports that four years ago, the vaping company came under fire for its fruity flavors and marketing direction. Fox News reports that four years ago, the vaping company came under fire for its fruity flavors and marketing direction. Fox News reports that four years ago, the vaping company came under fire for its fruity flavors and marketing direction. Critics say underage vaping surged as a result. Juul has since cut back on its marketing, and in 2019, the company stopped selling fruity, sweet cartridge flavors. . Still, sales have dramatically declined for the e-cigarette manufacturer. . The sale of all fruity e-cigarette flavors has since been banned by the FDA. Juul's impending departure would pave the way for Reynolds American Inc. and NJOY Holidings Inc. to corner the tobacco-flavored segment of the e-cigarette market. Juul's impending departure would pave the way for Reynolds American Inc. and NJOY Holidings Inc. to corner the tobacco-flavored segment of the e-cigarette market. Juul's impending departure would pave the way for Reynolds American Inc. and NJOY Holidings Inc. to corner the tobacco-flavored segment of the e-cigarette market. Fox News reports Juul will be able to file an appeal through the FDA, take the matter to court or file a new application with revised products. . Fox News reports Juul will be able to file an appeal through the FDA, take the matter to court or file a new application with revised products.

FDA Panel Endorses COVID Vaccines for Children Under 5

FDA Panel , Endorses COVID Vaccines, for Children Under 5. On June 15, an advisory panel to the United States Food and Drug Administration voted to recommend two COVID-19 vaccines for kids ages 5 and under. Yahoo reports that both Pfizer/BioNTech and Moderna were under review by the panel. . The unanimous FDA panel vote is the first step in what is predicted to be a quick authorization process. According to Yahoo, data from trials shows that both vaccines continue to protect against severe disease, hospitalization and death. According to Yahoo, data from trials shows that both vaccines continue to protect against severe disease, hospitalization and death. Yahoo reports that parents now have two options for how to vaccinate their children. Pfizer's vaccine for kids is delivered in three, three-microgram doses, while Moderna's vaccine is delivered in two shots of a 25-microgram dose. Our robust clinical study shows that three doses can provide protection for the circulating Omicron variant and offers promise for protection against potential future waves of COVID-19, Dr. Bill Gruber, Pfizer's Vaccine Clinical Research and Development head, via Yahoo. Our robust clinical study shows that three doses can provide protection for the circulating Omicron variant and offers promise for protection against potential future waves of COVID-19, Dr. Bill Gruber, Pfizer's Vaccine Clinical Research and Development head, via Yahoo. The committee’s support today is imperative to providing a critical tool for pediatricians, parents, and caregivers who eagerly await an option for children under five, Dr. Bill Gruber, Pfizer's Vaccine Clinical Research and Development head, via Yahoo. Both companies are now awaiting approval from the FDA and the CDC which will hold an advisory committee meeting on the topic over the weekend.

Pfizer's COVID Vaccine for Kids Under 5 Moves Closer to FDA Approval

Pfizer's COVID Vaccine for Kids Under 5 , Moves Closer to FDA Approval . Pfizer announced on June 1 that its application to the Food and Drug Administration (FDA) for the vaccine was complete. Pfizer announced on June 1 that its application to the Food and Drug Administration (FDA) for the vaccine was complete. The three-dose vaccine is for children between the ages of six months and five years. Pfizer released a statement detailing the application. Pfizer and BioNTech completed a rolling application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA)... , Pfizer Statement, via ABC News. ... of the 3-µg [microgram] dose of the Pfizer-BioNTech COVID-19 Vaccine.., Pfizer Statement, via ABC News. ... for children 6 months through 4 years of age (also referred to as 6 months to under 5 years of age) on June 1, 2022, Pfizer Statement, via ABC News. Pfizer reported an 80 percent effectiveness rate in children in May. The FDA also released a statement on June 1, confirming that the agency had accepted the Pfizer application. We recognize parents are anxious to have their young children vaccinated against COVID-19... , FDA Statement, via ABC News. ... and while the FDA cannot predict how long its evaluation of the data and information will take, , FDA Statement, via ABC News. ... we will review any EUA request we receive as quickly as possible using a science-based approach, FDA Statement, via ABC News. According to a poll conducted by the Kaiser Family Foundation in April of this year. ... just 18 percent of parents intend to have their children vaccinated once the vaccine is approved. 27 percent of parents stated that they will "definitely not" vaccinate their children against COVID

Bharat Biotech’s Covaxin safe for children of 2to18 years says Lancet Journal Oneindia News*News

The manufacturers of the Covid-19 vaccine Covaxin, Bharat Biotech have said that their vaccine is safe for use on children between the age group of 2 to 18 years. #Covaxin #BharatBiotech #LancetJournal

COVAXIN BOOSTER DOSE: EFFECTIVE AGAINST OMICRON AND DELTA VARIANT| OneIndia News* News

ICMR and Bharat biotech has found in a study that Covaxin booster dose is highly effective against delta and omicron variants. Lung disease, virus shedding and are reduced after the third dose of Covaxin. #covidupdate #covaxin #boosterdose

Covid-19 update: India logs 17,092 new cases and 29 deaths in last 24 hours | Oneindia News *news

According to the Union Health ministry's data, India added 17,092 Covid cases and 29 Covid-related deaths in the last 24 hours. #CovidIndia #Covid19 #CovidCases #CoronaDeaths