India in talks to buy 50 million doses of Pfizer vaccine

 India is in talks to buy 50 million doses of Pfizer Inc and German partner BioNTech SE's COVID-19 vaccine, the Wall Street Journal reported https://www.wsj.com/articles/india-looks-to-western-covid-19-vaccines-to-ease-supply-shortage-11628674884?mod=latest_headlines on Wednesday, citing people familiar with the matter.

A Pfizer spokesperson said it was in talks with the government to supply vaccines, but declined to provide further details. The Indian health ministry did not immediately respond to Reuters request for comment.

To be sure, the drugmaker has not yet sought permission for use of its vaccine in India.

India rolled out one of the world's largest vaccination drives earlier this year and has been relying heavily on the AstraZeneca vaccine produced by the Serum Institute of India and a home-grown shot produced by Bharat Biotech.

While the coronavirus cases in the country have eased from a devastating peak in April and May, government officials have said the second wave is not over.

Experts have said that large-scale vaccination is India's best bet against the fast-spreading Delta variant of the coronavirus.

The country has fully vaccinated more than 115 million people, which is about 12% of its estimated 944 million adults, according to latest government data https://dashboard.cowin.gov.in/#skip_to_main. The government aims to vaccinate the entire adult population by December.

Authorities are also in an advanced stage of negotiations with Johnson & Johnson, which has a deal with India-based Biological E. Ltd, to manufacture as many as 600 million doses, starting as soon as this month, the Journal reported.

Last week, the country approved J&J's one-shot vaccine for emergency use, adding to the vaccines from AstraZeneca, Bharat Biotech, Russia's Gamaleya Institute and Moderna that have been granted such approval.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-India-in-talks-to-buy-50-million-doses-of-Pfizer-vaccine-WSJ-36128767/

CDC recommends pregnant women get COVID-19 vaccine

 Pregnant women should be vaccinated against COVID-19, based on a new analysis that did not show increased risk for miscarriage, the U.S. Centers for Disease Control and Prevention said on Wednesday.

The CDC said it has found no safety concerns for pregnant people in either the new analysis or earlier studies. It said miscarriage rates after vaccination were similar to the expected rate. Pregnant women can receive any of the three vaccines given emergency authorization -- Pfizer, Moderna or Johnson & Johnson.

The agency had not previously recommended pregnant women get vaccinated but had said that they should discuss vaccination with their health care providers.

Sascha Ellington, team lead for the Emergency Preparedness and Response team in CDC's Division of Reproductive Health, said that vaccine uptake in pregnant women has been low, with only 23% receiving at least one vaccine dose.

"We want to increase that," Ellington said, noting that the agency was working on strategies to have obstetricians and gynecologists become vaccine providers. "We want women to be protected. We're not seeing any safety signals and so the benefits of vaccination really do outweigh any potential or unknown risks."

Pregnancy increases the risk of severe illness from COVID-19, according to the CDC, and COVID-19 during pregnancy increases the risk for preterm birth.

The CDC said it now recommends all people 12 years and older get vaccinated against COVID-19, including people who are pregnant, breastfeeding, trying to get pregnant or might become pregnant in the future.

"We are aware of the myths that have been spreading related to fertility. They are not based on any evidence. There's no science that backs that up," Ellington said. "We hope this helps."

The new guidance comes as cases and hospitalizations https://tmsnrt.rs/2WTOZDR have surged across the country in the past month. Some hospitals in Arkansas, Florida, Louisiana and Mississippi have run out of beds, and the outbreak is spreading beyond the epicenter in the U.S. South to Oregon and Washington state.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-CDC-recommends-pregnant-women-get-COVID-19-vaccine-36136968/

Valneva Initiates Further Phase 3 Trial for COVID-19 Vaccine Candidate

  Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced the initiation of a further Phase 3 trial (VLA2001-304) for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

VLA2001-304 aims to generate data in the elderly and is also designed to potentially enable variant-bridging through immune-comparability. Data from this study are expected to complement ongoing clinical trials and support additional regulatory submissions.

VLA2001-304, which will be conducted in New Zealand, will recruit approximately 150 participants aged 56 years and older (Cohort 1) with the aim of generating additional safety and immunogenicity data in this age group following vaccination with VLA2001 (two doses 28 days apart).

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “The fight against COVID-19 continues and it’s extremely important that we continue to gather as much data as possible in all age groups across the population. Everyone should have access to technology best suited to protect them against this virus. We have also been working on Variants of Concern as part of our continued efforts to stay ahead of the virus causing COVID-19 especially since we believe that our inactivated, whole-virus platform will be adaptable across variants. Hence we are extremely pleased to be able to invest in this very important additional clinical trial”.

In June 2021, Valneva announced that it had completed recruitment for VLA2001’s pivotal Phase 3 trial “Cov-Compare” (VLA2001-301) with over 4,000 randomized participants. Valneva plans to make regulatory submissions for initial approval in the fourth quarter of 2021, subject to successful Cov-Compare data.

https://www.globenewswire.com/news-release/2021/08/11/2279030/0/en/Valneva-Initiates-Further-Phase-3-Clinical-Trial-for-its-COVID-19-Vaccine-Candidate.html

VA decides against adding Biogen's Aduhelm to its formulary

 The Department of Veterans Affairs has decided to not include Biogen’s pricey new Alzheimer’s drug Aduhelm on its formulary, and its PBM even went so far as to recommend against offering it, noting “the lack of evidence of a robust and meaningful clinical benefit and the known safety signal.”

The decision, which is one of the first nationwide determinations on whether to cover the controversial new drug, also recommends that if Aduhelm is to be used by exception, then it should be used “only in highly selected patients by experts and centers that have the necessary diagnostic and management expertise — and only by those with the needed resources for close monitoring to assure safety,” Endpoints News has learned.

https://endpts.com/exclusive-va-decides-against-adding-biogens-aduhelm-to-its-formulary-as-pbm-shuns-controversial-alzheimers-drug/

CDC Forced to 'Adjust' Sunday's Fla. 'Record' COVID Count Down Almost 50% As State Health Dept. Cries Foul On Data

 The CDC has been forced to "adjust" its Covid-19 case tracker for Florida after the state's health department took to Twitter earlier this week to call out incorrect data.

As of Tuesday, the CDC "was working with the state’s health department" to get the data right, according to a report from Fox News. 

Florida's health department called out the incorrect CDC information publicly, stating earlier this week: "Wrong again. The number of cases @CDCgov released for Florida today is incorrect. They combined MULTIPLE days into one. We anticipate CDC will correct the record."

The CDC had reported 28,317 new Covid cases on Sunday, but had "adjusted" the number to 19,584 cases by Tuesday, the report says. Florida's health department claimed that there were 15,319 cases on Sunday a number that is almost 50% lower than the CDC's originally reported number. 

"On Tuesday, the U.S. Centers for Disease Control and Prevention reported the state has surpassed 20,000 for its 7-day average of new cases, a day after the federal agency misreported numbers given by the Florida Department of Health by combining data from the last three days into two," Fox reported on Wednesday, after first pointing out the data discrepancy earlier in the week.

Florida's hospitalizations were up by more than 1,110 to 14,787 on Tuesday. 

Recall, earlier this week we noted that Governor Ron DeSantis was threatening to withhold salaries from school officials who defied his mask mandate ban. 

According to a statement issued by DeSantis' office - just days after his threat to cut funding resulted in a 'pause' on a proposed mask mandate in Broward County - one potential consequence for defiant school officials would be a loss of income.

“With respect to enforcing any financial consequences for noncompliance of state law regarding these rules and ultimately the rights of parents to make decisions about their children’s education and health care decisions, it would be the goal of the State Board of Education to narrowly tailor any financial consequences to the offense committed. For example, the State Board of Education could move to withhold the salary of the district superintendent or school board members, as a narrowly tailored means to address the decision-makers who led to the violation of law," reads the statement.

...unintentional? Too late to correct all those Sunday morning political shows 'gloating' over DeSantis' state outbreak.

https://www.zerohedge.com/markets/cdc-forced-adjust-sundays-florida-covid-case-count-lower-almost-50-after-state-health

CohBar: Positive Topline Results in Phase 1a/1b Study of CB4211 for NASH and Obesity

 

• CB4211 was well-tolerated and appeared safe with no serious adverse events
  

• Robust reductions in ALT and AST

• Reduction in glucose and trend towards body weight reduction

• Company to host conference call and webcast

Conference Call:

Date: August 10, 2021
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

• Dial-in U.S. and Canada: (877) 300-8521

• Dial-in International: (412) 317-6026

• Conference ID No.: 10159293
  

Slide Presentation

• Please visit https://us02web.zoom.us/j/84796437737?pwd=R2t0eEFRVDVlVDVZMTdhT0pGWVVsUT09 and enter password CWBR, or

• Go to www.cohbar.com and click on CohBar Q2 2021 Investor Presentation at the top of homepage.

https://finance.yahoo.com/news/cohbar-announces-positive-topline-results-200200559.html

Hoth mRNA 'Frameshifting' Therapy HT-KIT for Mast Cell Cancers Reduces Size, Spread

 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today highlights recent findings from North Carolina State University, that its new treatment for mast cell cancers, known as HT-KIT, reduces the number of mast cells by "mutating" the messenger RNA (mRNA) before it can deliver instructions for manufacturing the gene responsible for cell proliferation.

"Current treatments for mast cell cancers target signaling from the receptor encoded by the c-KIT gene, and the efficacy of current therapies can be negatively affected by c-KIT mutations associated with disease development," says Glenn Cruse, assistant professor of immunology at North Carolina State University and a Scientific Advisor to Hoth and corresponding author of the research. "We are targeting the gene itself, regardless of mutation. If we target the gene that drives progression, then we can target the disease."

"We are altering the message that makes the protein – flipping an 'on' switch to 'off,'" Cruse says. "If you get mRNA to produce a protein that is mutated and severely truncated, your cell will recognize that and degrade the message so that the protein isn't produced."

The researchers used their frameshifted c-KIT mRNA approach on mast cell leukemia cells in vitro and found that KIT protein expression, signaling and function were reduced. The cancer cells stopped proliferating and began dying within hours. In a mouse model, tumor growth and infiltration of other organs were reduced, and tumor cell death increased when the frameshifted c-KIT mRNA was induced.

https://finance.yahoo.com/news/hoth-therapeutics-mrna-frameshifting-therapy-130100287.html