India's Serum Institute ties up with industry in push to vaccinate rural areas

 The Serum Institute of India (SII) said on Friday it had partnered with an industry body to expand the reach of COVID-19 shots in India’s countryside as it had “plenty of supply” of the AstraZeneca drug.

India has reported more than 31.5 million coronavirus infections in the world, the most after the United States, with 423,217 deaths.

While some 452 million vaccine doses have been administered, the pace of inoculations in rural areas, where two-thirds of India’s 1.35 billion people live, has lagged that of urban centres.

SII, the world’s largest vaccine maker, will be working with the Confederation of Indian Industry (CII), which has set up vaccination camps in smaller towns and rural areas.

“While SII has manufactured the vaccine at scale within a short period of time, it is essential that all stakeholders work together towards carrying out the inoculations,” CEO Adar Poonawalla said about its version of the AstraZeneca drug known as Covishield.

SII stopped all vaccine exports in April to meet India’s own demand and has forecast resuming foreign shipments only towards end-2021. Its monthly Covishield production is expected to nearly double to 120 million doses from April levels.

“India’s post-pandemic growth critically rests on how soon the eligible population is vaccinated and economic activities can return to normal,” said CII President T.V. Narendran.

https://www.reuters.com/article/health-coronavirus-india-vaccine/indias-serum-institute-ties-up-with-industry-in-push-to-vaccinate-rural-areas-idUSKBN2F016N

COVID vaccine protection highly likely to wane over time - UK advisers

 The protection that vaccines give against coronavirus infection, and potentially severe disease, is highly likely to wane over time so vaccine campaigns will continue for years to come, scientists told the British government's advisory group.

"It is highly likely that vaccine induced immunity to SARS-CoV-2 infection, and potentially severe disease (but probably to a lesser extent) will wane over time," according to an executive summary of a document considered by the government's Scientific Advisory Group for Emergencies (SAGE).

"It is therefore likely that there will be vaccination campaigns against SARS-CoV-2 for many years to come, but currently we do not know what will be the optimal required frequency for re-vaccination to protect the vulnerable from COVID disease," the scientists said.

The document, titled "How long will vaccines continue to protect against COVID?", was written by prominent virologists and epidemiologists from Imperial College London, University of Birmingham and Public Health England.

Britain has approved and is using three shots - Oxford-AstraZeneca, Pfizer-BioNTech and Moderna - in a mass vaccination programme that started in December 2020.

Real world data show that these vaccines protect with 95% or greater effectiveness against the Alpha variant that dominated in Britain in early 2021, the scientists said, although the ability of the shots to protect against infection and onward transmission was lower.

They said it might be expected that vaccine effectiveness would remain high for severe disease but effectiveness against mild disease and infection could fall off over time.

Anecdotal reports from Britain and Israel, which rolled out a comprehensive early campaign, supported that concept, they said.

Israel will begin offering a third shot of the Pfizer-BioNTech COVID-19 vaccine to people aged over 60, a world first in efforts to slow the spread of the highly contagious Delta variant.

Since the emergence of the Delta variant, the Israeli health ministry has twice reported a drop in the vaccine's efficacy against infection and a slight decrease in its protection against severe disease.

In a separate report to the UK government on July 22, scientists said there was a "realistic possibility" that new strains could emerge that could lead to more widespread severe disease or evade the impact of the current vaccines.

The emergence of such strains could lead to a return to tighter controls and lockdowns, with a consequent impact on economic activity.

https://finance.yahoo.com/news/1-covid-vaccine-protection-highly-144128287.html

Why Does CDC Want the Vaccinated Tested? One Word: Delta

 Vaccinated people should be tested for COVID-19 and mask up after coming into contact with an infected person, according to updated CDC guidelines released this week.

The change quietly accompanied the agency's new masking recommendations for areas of substantial and high transmission and K-12 schools, as data continue to accrue about the more transmissible Delta variant and the risk for vaccinated people contracting and spreading the virus.

The CDC now says even if someone is fully vaccinated, if they have a known exposure to "suspected or confirmed" COVID-19, they should be tested 3 to 5 days afterward. Fully vaccinated people should then wear a mask in indoor settings for 14 days or until they test negative for the virus, the agency added.

"Our updated guidance recommends vaccinated people get tested upon exposure regardless of symptoms. Testing is widely available," CDC Director Rochelle Walensky, MD, told the New York Times by email.

Testing vaccinated people took on new significance, given the CDC's Tuesday press briefing where the agency teased new data about the Delta variant. They explained that not only can vaccinated people transmit the virus, but they have comparable viral loads to unvaccinated people. Data from the Times late Thursday referenced a report where 882 COVID-19 cases were linked to a Fourth of July celebration in Provincetown, Massachusetts, and three-quarters of those were fully vaccinated.

CDC documents shared by the Washington Post elaborated about how viral loads were nearly identical between 80 vaccinated people and 65 unvaccinated people in that outbreak (median Ct values 21.9 and 21.5, respectively).

The documents also noted that breakthrough cases reported to national surveillance have around a 10-fold increase in viral load for the Delta variant compared with Alpha and other strains.

"Vaccines prevent >90% of severe disease, but may be less effective at preventing infection or transmission -- therefore, more breakthrough and more community spread despite vaccination," according to the CDC's internal document.

The agency shared data showing the Delta variant is as transmissible as chicken pox, and more transmissible than Ebola, the 1918 flu, and smallpox. Not only that, but data from Canada, Singapore, and Scotland suggested Delta might also be more virulent than other strains, with higher odds of hospitalization, ICU admission, or death.

In terms of next steps for communicating these findings, CDC must "acknowledge the war has changed," the document stated.

https://www.medpagetoday.com/infectiousdisease/covid19/93820

AbbVie expects Botox boom to power annual earnings

 

Drugmaker AbbVie Inc on Friday raised its 2021 profit forecast on expectations that a rapid uptick in demand for its Botox anti-wrinkle injection due to the easing of COVID-19 curbs would continue for the rest of the year.

Sales of the drug for cosmetic uses rose two-fold to $584 million in the second quarter, trouncing analysts' estimates of $483 million as vaccinations encouraged people to resume non-essential procedures after being holed up at home for months.

The company acquired the drug last year as part of its $63 billion purchase of Allergan. Company executives said on an earnings call that sales of products gained through the deal were on track to outpace Allergan's historical performance.

Increased investment in Botox and other aesthetic products is helping boost demand, Chief Executive Officer Richard Gonzalez said.

"About two-thirds of the performance, I think, is fundamental demand and maybe one-third of it is pent-up demand," Gonzalez added.

The company forecast full-year adjusted earnings between $12.52 and $12.62 per share, compared with $12.37 to $12.57 per share previously. Analysts expected 2021 earnings per share of $12.61, according to Refinitiv IBES data.

AbbVie also reported a 4.8% rise in quarterly sales of its best-selling drug Humira to $5.07 billion, roughly in line with expectations.

But sales of the drug, which is facing rivals in Europe, fell 6% on a reported basis in international markets while rising 7.1% in the United States.

AbbVie said the recent approval of Biogen's Alzheimer's disease drug had increased interest in treatments that clear brain plaques, a likely contributor to the disease.

The company expects to start testing a drug for Alzheimer's that works on the same mechanism by the end of the year or early next year.

https://www.marketscreener.com/quote/stock/ABBVIE-INC-12136589/news/AbbVie-expects-Botox-boom-to-power-annual-earnings-36017713/

Walmart to require masks for retail workers in high-risk U.S. counties

 Retail giant Walmart Inc has made it mandatory for its workers in U.S. counties with substantial or high transmission of coronavirus to wear masks again in its stores, clubs and distribution centers, according to a memo.

The move comes as the U.S. Centers for Disease Control and Prevention (CDC) said earlier this week Americans fully vaccinated against COVID-19 should go back to wearing masks in indoor public places in regions where the coronavirus is spreading rapidly.

Walmart retail workers would also post signage at its stores to encourage customers to wear masks.

https://www.marketscreener.com/news/latest/Walmart-to-require-masks-for-retail-workers-in-high-risk-U-S-counties-memo--36021718/

ERYTECH Granted FDA Fast Track for Eryaspase in Hypersensitive Leukemia

 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company, leader in red blood-cell based cancer therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted eryaspase Fast Track designation for the treatment of acute lymphocytic leukemia (ALL) patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase (PEG-ASNase).

“This is yet another significant milestone and meaningful inflection point in advancing our lead product candidate eryaspase, further supporting our recently announced intention to submit a BLA for eryaspase in hypersensitive ALL patients,” said Gil Beyen, CEO of ERYTECH. “We believe that the FDA’s Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.”

Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival, highlighting the need for additional asparaginase based treatment options.

In December 2020, positive results from a Phase 2 trial evaluating the safety and enzyme activity of eryaspase in primarily pediatric ALL patients who developed hypersensitivity reactions to pegylated asparaginase were presented by the Nordic Society of Pediatric Hematology and Oncology at the 2020 American Society of Hematology annual meeting. This data demonstrated that eryaspase, in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.

https://finance.yahoo.com/news/erytech-granted-u-fda-fast-200500031.html

RxSight, Inc. Prices IPO

 RxSight, Inc., an ophthalmic medical device company, today announced the pricing of its initial public offering of 7,350,000 shares of common stock at a public offering price of $16.00 per share. The gross proceeds to RxSight® from the offering are expected to be $117.6 million, before deducting underwriting discounts and commissions and offering expenses. In addition, RxSight has granted the underwriters a 30-day option to purchase up to an additional 1,102,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. RxSight’s common stock is expected to begin trading on the Nasdaq Global Market on July 30, 2021, under the ticker symbol “RXST.” The offering is expected to close on August 3, 2021, subject to the satisfaction of customary closing conditions.

J.P. Morgan Securities LLC and BofA Securities, Inc. are acting as joint book-running managers of the offering and as representatives of the underwriters. SVB Leerink LLC is also acting as a book-running manager of the offering. Wells Fargo Securities, LLC is acting as lead manager for the offering. BTIG, LLC is acting as co-manager for the offering.

https://www.globenewswire.com/news-release/2021/07/30/2271883/0/en/RxSight-Inc-Announces-Pricing-of-Initial-Public-Offering.html