California to lift stay-at-home orders on Monday

 California is expected to lift its regional stay-at-home orders across the state on Monday, moving counties back into the tier-based reopening framework, local media reported.

California Governor Gavin Newsom's office has decided to lift the orders as ICU availability in the regions that remained under the stay-at-home order, including the Bay area and Southern California are projected to rise above the 15% threshold that triggered the lockdown measures, according bit.ly/3sSPOfp to San Francisco Chronicle.

According to the report, counties will move back to the tiered system, with most regions across the state expected to move into the purple tier, meaning personal care services like hair salons can re-open with modifications and restaurants can open for outdoor service.

California, the United States’ most populous state, emerged as a leading U.S. epicenter of the pandemic despite re-imposing some of the most stringent restrictions on social gatherings and business activity.

Total cases in the United States crossed 25 million on Sunday, even as states accelerate their vaccine distribution. California has reported over 3.1 million cases and 36,745 deaths so far, a Reuters tally showed.

But the number of new infections appear to be slowing after a surge following the Holiday season.

The state’ top health official said earlier this month that the number of hospitalized coronavirus patients statewide had steadily declined, showing signs of the virus leveling off.

Strict stay-at-home orders were renewed for much of California in December to avert a crisis in hospitals.

https://www.reuters.com/article/us-health-coronavirus-usa-california/california-to-lift-stay-at-home-orders-on-monday-report-idUSKBN29U0NC

Pfizer asks South Korea OK COVID-19 vaccines before February rollout

 Drugmaker Pfizer Inc has filed an application seeking approval of its coronavirus vaccines to be used in South Korea as the country gears up to begin inoculations next month, authorities said on Monday.

The Ministry of Food and Drug Safety said it aims to reach a decision within 40 days after cutting its previous deliberation period of up to 180 days to fast-track the approval and speed up the vaccination process.

“Pfizer submitted the request today for its vaccines produced in Belgium,” the ministry said in a statement.

“We will thoroughly review their safety and effectiveness in cooperation with professional examiners and outside experts so that our people can access safe and effective COVID-19 vaccines.”

South Korea has said its first batch of vaccines consisting of 100,000 doses of Pfizer products for 50,000 people could arrive before the Lunar New Year holidays, which begin on Feb. 11, via global distribution scheme COVAX.

Authorities have started setting up vaccination centres, designating some 250 indoor gyms and theatres nationwide, with the goal of vaccinating up to 70% of its 52 million population until September.

The country has secured 106 million doses of coronavirus vaccines from COVAX, Pfizer, Moderna, AstraZeneca and Johnson & Johnson, and is also in talks to buy 40 million doses of products from Novavax.

https://www.reuters.com/article/us-health-coronavirus-southkorea-vaccine/pfizer-requests-south-korea-approval-covid-19-vaccines-ahead-of-february-rollout-idUSKBN29U0QE

Hong Kong formally approves Fosun Pharma-BioNTech vaccine

 Hong Kong has formally approved use of the Fosun Pharma-BioNTech vaccine, the city government said on Monday, the first COVID-19 vaccine to be accepted in the Asian financial hub.

The first batch of around one million doses is expected to arrive in the second half of February, the government added in a statement.

The move comes with Hong Kong lagging other developed cities in rolling out vaccines and after mainland China started its vaccine program in July last year.

Hong Kong has secured a total of 22.5 million doses of COVID-19 vaccine from Fosun Pharma-BioNTech, China’s Sinovac Biotech and Oxford-AstraZeneca, the city’s leader Carrie Lam said in December.

Fosun Pharma is German drug manufacturer BioNTech’s partner in Greater China including in special administrative regions Hong Kong and Macau. Fosun is responsible for cold-chain management, storage and distribution.

China’s Sinovac vaccine is likely to arrive in Hong Kong after BioNTech’s vaccine in February, with AstraZeneca’s vaccine due by the middle of the year.

Home to 7.5 million residents, Hong Kong has a separate approval process from the mainland for vaccines.

The city has recorded nearly 10,000 coronavirus cases and 166 deaths since Jan 2020. Cases have spiked over the past week after an outbreak in an old residential building located in a busy commercial and residential area.

In China, a vaccination programme for emergency use started in July with products from domestic manufacturers Sinopharm and Sinovac Biotech.

The program was widened in December to focus on additional priority groups including employees in the cold-chain industry, transportation sector and fresh food markets.

China’s state media outlets have run a series of articles criticising Western COVID-19 vaccines in the past week, including Pfizer’s, while touting China-made vaccines as safer and more accessible.

https://www.reuters.com/article/us-health-coronavirus-hongkong-vaccine/hong-kong-formally-approves-fosun-pharma-biontech-vaccine-idUSKBN29U0Z7

EU to require advance registration of COVID-19 vaccine exports

 The European Union will require pharmaceutical companies producing COVID-19 vaccines inside the bloc to register in advance any exports of doses to third countries, an EU official said on Monday. The move comes after AstraZeneca on Friday unexpectedly announced a large cut in supplies of vaccines to the bloc for the first quarter of the year. The executive European Commission would create a transparency register for vaccine exports outside the bloc, the official told Reuters, adding that the new rule was due to enter into force in the coming days. “Export licences for humanitarian purposes will be regularly issued,” the official said.

https://www.reuters.com/article/us-health-coronavirus-eu/eu-to-require-advance-registration-of-covid-19-vaccine-exports-idUSKBN29U1C3

Global life insurers impose curbs, worried about long-term pandemic risks

 Global life insurers are taking steps to curb payouts stemming from the coronavirus pandemic, including long-term health consequences that are not fully understood, industry sources told Reuters.

Life insurers, including Prudential Financial Inc, and Aviva PLC, are now imposing waiting periods before COVID-19 patients, including those who have recovered, can apply for coverage, executives and spokespeople said. Some are also limiting coverage for certain age groups.

These changes come as some reinsurers demand new safeguards from life insurers they backstop, and as the industry struggles to ascertain the extent of problems caused by the novel coronavirus.

COVID-19 has killed over 2.1 million people globally and infected nearly 100 million, according to a Reuters tally. (tmsnrt.rs/39Qa1d2)

Some victims suffer long-term consequences including severe respiratory problems, organ damage, circulatory impairment and chronic fatigue. Three weeks after recovery, 10% of COVID-19 patients are still unwell and up to 5% feel sick for months, according to scientists at King’s College London.

The pandemic has also caused a mental-health crisis for those who could not say goodbye to loved ones or have been isolated for months, while exacerbating substance-abuse issues for others.

It is too early to know how many people will file claims for death, long-term illness or disability as a result, but insurers worry the consequences could last for decades.

“We have attempted as a company to strategize about modeling this and have made some headway but are far from the crystal ball that is able to predict this,” said Dr. Paulo Bandeira Pinho, chief medical director of Optimum Re Insurance Co.

Optimum has met with life-insurer customers, including Prudential Financial, to map out long-term risks and possible financial impacts.

Prudential now imposes a minimum 30-day waiting period for recovered COVID-19 patients.

“Ultimately, many of the long-term implications of the pandemic are still unknown,” said Prudential’s Vice President of Operations Keith Bexell. “As the long-tail effects become better understood, our approach to underwriting may adjust as necessary.”

Since April, British life insurer LV= has postponed applications from anyone who was diagnosed with COVID-19, experienced symptoms or lived with someone who got sick, according to an underwriting policy on its website.

Aviva PLC also imposes a “short” delay for those who had COVID-19 or similar symptoms during the past 30 days, a spokesperson said.

VACCINE HOPES

Life insurers are in the business of hedging risks decades in advance. Since the start of the pandemic, the industry has said it would probably not cause major financial damage, partly because they were not seeing a swell of claims.

Global data are not available for 2020. In the United States, 8% of reported group life insurance claims from April to August attributed the cause of death to COVID-19, according to the U.S. Society of Actuaries.

Companies told Reuters the impact so far has been minimal – with LV= seeing COVID-19 affect just 2% of applications and Aviva still covering more than 9 in 10 customers – but they are taking precautionary steps anyway because of long-term risks.

Apart from those who had the disease, Optimum Re’s Pinho worries about a “wave of widows and widowers, children and parents” with shortened lifespans.

Plus, the pandemic reduced preventative health screenings, causing another set of risks, said Chris Behling, SwissRe’s head of life and health underwriting for the Americas.

However, it is not all doom and gloom. Insurers expect vaccines to dramatically improve assumptions.

Some also pointed to better mortality statistics in countries that imposed tight restrictions on travel and socializing, as well as a study from Britain’s Institute and Faculty of Actuaries that suggested surviving populations may have a higher life expectancy.

And, if insurers become too stingy with coverage, they may lose valuable customers.

For instance, LV= is excluding mental-health issues from some policies that cover critical illness and income protection for up to 12 months, said Justin Harper, the company’s head of marketing.

“It’s probably the appropriate decision to make, given we’re trying to balance the access but also the risk management,” Harper said.

https://www.reuters.com/article/us-health-coronavirus-insurance/global-life-insurers-impose-restrictions-worried-about-long-term-pandemic-risks-idUSKBN29U0FC

CVS completes 1st round of COVID-19 vax at 8,000 U.S. nursing facilities

 Drugstore chain CVS Health Corp said on Monday it has completed administering the first round of COVID-19 vaccination at about 8,000 U.S. nursing facilities.

Administration of second doses is underway and expected to be completed within four weeks, the company said.

CVS says its long-term care vaccination effort remains on track, with nearly two million doses administered to date. 

https://www.reuters.com/article/us-health-coronavirus-cvs-health-vaccine/cvs-completes-first-round-of-covid-19-vaccination-at-8000-u-s-nursing-facilities-idUSKBN29U1CL

Roche targets wet AMD with faricimab and its 16-week regimen

 Twin late-stage trials of Roche’s ophthalmology drug faricimab have hit the mark in “wet” age-related macular degeneration trial, as the company’s challenge to rivals from Novartis and Bayer strengthens.

With faricimab Roche is aiming to outperform rivals in a highly competitive market by doubling the time taken between doses compared with standard care to 16 weeks.

It’s similar to the approach taken by Novartis with its Beovu, which is already approved and can be taken at 12-weeks dosing frequency in certain cases, although there have been concerns raised about potential safety issues.

Roche looks to have outdone Novartis with its almost quarterly dosing regimen and cutting the number of visits to clinics would be welcomed by patients.

It could reduce the cost and administrative burden for healthcare systems if the drug is priced keenly.

Supportive phase 3 trial results from the twin YOSEMITE and RHINE studies in diabetic macular oedema announced at the beginning of January are already due to be filed with regulators this year.

Roche said the TENAYA and LUCERNE studies achieved their goal, with faricimab producing comparable improvements in vision when dosed every 16 weeks, compared with Bayer/Regeneron’s Eylea (aflibercept) doses every eight weeks.

Like the diabetic macular oedema studies, TENAYA and LUCERNE are non-inferiority studies, where the goal is to match the performance of a competitor.

Roche said that nearly half (45%) of people in both studies were treated with faricimab every 16 weeks during the first year.

Roche said that in both studies, faricimab was generally well-tolerated, with no new or unexpected safety signals identified.

Detailed findings will be presented next month at the Angiogenesis, Exudation and Degeneration 2021 conference in Miami.

Findings will be submitted to regulators around the world including the FDA and European Medicines Agency, Roche said.

TENAYA and LUCERNE are two identical, phase III studies, testing the efficacy and safety of faricimab compared to aflibercept in 1,329 people living with neovascular age-related macular degeneration (671 in TENAYA and 658 in LUCERNE).

The studies each have two treatment arms: faricimab 6.0 mg administered at fixed intervals of every eight, 12 or 16 weeks, selected based on objective assessment of disease activity at weeks 20 and 24; Eylea 2.0 mg administered at fixed eight-week intervals.

In both arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.

The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score.

This is the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart from baseline through week 48.

Secondary endpoints included safety and the percentage of participants in the faricimab arm receiving treatment every eight, 12 and 16 weeks.

Faricimab is a bispecific antibody that targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive a number of retinal conditions.

https://pharmaphorum.com/news/faricimab/