FS-ISAC Coronavirus Update, Feb. 5, 2021

Johnson & Johnson on Thursday submitted to the Food and Drug Administration an application for emergency authorization for its one-dose coronavirus vaccine, putting the company on track to potentially begin shipping it by early March.

• The agency has scheduled a meeting with its outside advisory panel, which will vote on whether the Food and Drug Administration should authorize the vaccine on February 26, according to people familiar with the planning.
• Regulators will then have about three weeks to pore over a large and complex application that includes clinical and manufacturing data, with a decision on whether to authorize the vaccine that could come within days of that meeting.

• This same regulatory process for Pfizer’s vaccine took a little over three weeks, while Moderna’s candidate took a little more than two.
• The vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, and 85% effective overall at preventing hospitalization and death in all regions where it was tested.
• Efficacy against moderate and severe disease, measured one month after the shot, ranged from one country to another, with 72% in the US, 66% in Latin America and 57% in South Africa.
• The vaccine, made through a collaboration with the company's vaccine division, Janssen Pharmaceutical, and Beth Israel Deaconess Medical Center, is considered versatile since it is considered stable for up to three months kept in regular refrigerated temperatures and doesn’t need the deep freeze like Pfizer’s.
• The company said it expects to have product available to ship immediately following authorization and expects to supply 100 million doses to the US in the first half of this year.

Headlines

• Health authorities are still learning about the new coronavirus variants, and whether current health measures are as effective against them - but increasing data suggests that the B.1.1.7 variant, first identified in the United Kingdom, may be deadlier than the original strand, Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said Wednesday.
• Epidemiologist Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, compared a United Kingdom variant to a “Category 5 hurricane” churning off the coast, saying some strains could cause a “major surge” in new cases in the US, and adding that “It’s going to take much more than vaccine to keep this variant at bay and not to have potentially a major surge in just the weeks ahead.”
• Dr. Anthony S. Fauci, the nation’s top infectious disease expert and President Biden’s chief medical adviser for Covid-19, urged people to keep Super Bowl celebrations to a minimum by watching the game at home, pointing to coronavirus spikes that followed celebrations and holidays like Christmas and New Year’s.
• Dr. Anthony Fauci said Thursday that people who've had Covid-19 should still get the second dose of vaccine and should follow US Food and Drug Administration guidance of getting two shots either 21 or 28 days apart, explaining “Although prior infection may help boost vaccination, we currently do not have enough evidence showing it would be comparable to vaccination for most people.”
• People who have had Covid-19 should still get vaccinated, but it’s OK to temporarily delay getting a shot, Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said today, adding that reinfection is possible and the vaccine may help boost the immune system.
• Dr. Anthony Fauci said today that he hopes there will be data to support Covid-19 vaccinations for older children by the late spring or summer, and when asked if it’s safe for children to go about their lives if all adults are vaccinated but children aren’t, explained that “the situation in your community is a key factor here,” adding that while virus levels are high in the community, everyone needs to take steps such as wearing masks and social distancing.
• Around 70% of the total coronavirus vaccine doses administered globally have been in the 50 wealthiest countries compared to only 0.1% administered in the 50 poorest countries, according to analysis by the International Federation of Red Cross and Red Crescent Societies, who described the disparity as alarming and said it could result in “deadly and devasting” consequences, warning that if large areas across the globe remain unvaccinated, the virus will carry on circulating and mutating.
• Weekly screening of all students, teachers, and staff using rapid antigen tests can reduce in-school infections by 50% for high schools and 35% for primary schools, a new study from the Rockefeller Foundation and the Department of Health and Human Services found, with the different results due to high schoolers having a greater number of contacts and higher rates of transmission.
• American consumers may be about to get the first standards for face masks, as ASTM International, an international technical standards organization, and the National Personal Protective Technology Laboratory, are working on standards to "establish minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings."
• Economists expect to see 50,000 total jobs created when the monthly Labor Department report is released Friday morning, but the swing factor will be whether employers in restaurants, hotels and recreational activities were able to retain and add workers or whether they continued to be hit by virus-related restrictions.
• Another 779,000 Americans filed for first-time unemployment benefits on a seasonally adjusted basis in the last week of January, the Labor Department said Thursday, stressing once again that the jobs recovery isn't in great shape, and on top of regular jobless benefits, 348,912 workers filed for Pandemic Unemployment Assistance, which is available for people such as the self-employed or gig workers.
• California-based drone delivery start-up Zipline is developing cold-chain storage, and starting this April, it plans to have drones that can deliver frozen and ultra-low temperature Covid-19 vaccines and medical products in the markets where it operates.

Vaccines – US

1. About 35.2 million doses of vaccine have been administered in the US, according to data published Thursday by the US Centers for Disease Control and Prevention, about 61% of the 57,489,675 doses distributed and around 1.3 more administered doses reported since yesterday, which is also the seven-day average of doses administered daily.
2. About 8.5% of the US population - nearly 28 million people - have now received at least one dose of a coronavirus vaccine. Nearly 7 million people, or 2%, have been fully vaccinated, the Centers for Disease Control and Prevention reported today.
3. The number of vaccine doses delivered over the last week dropped 22.5%, but the number of doses administered rose 13.5%, according to a report from the Department of Health and Human Services.
4. Black residents are significantly more likely than White residents to live more than a mile from the closest vaccination facility, according to an analysis measuring barriers to vaccine access by the University of Pittsburgh School of Pharmacy and West Health Policy Center, an update to the open-access VaxMap, which was created in December to measure vaccination facility density and driving distance of all residents to locations where vaccines will be administered.
5. Younger Black adults are far more hesitant to get the vaccine than their elders, according to the new survey of 1,340 respondents released by the National Foundation for Infectious Diseases, and results also found that Black women across all age groups were more uncertain about the vaccines than Black men.
6. California is now administering about one million doses of the vaccine each week, Governor Gavin Newsom said yesterday, a rate two to three times higher than the initial rollout, but the state’s rollout has hit some snags due to supply struggles.
7. Illinois will use about 97,000 doses earmarked for nursing homes to vaccinate people 65 and older, teachers and other members eligible under phase 1B.
8. Michigan Governor Gretchen Whitmer said Thursday afternoon more than one million doses of vaccines have now been administered in the state, and that every resident living in a nursing facility who wants a shot has been given the opportunity to receive their first dose.
9. New York’s state health commissioner denied New York City Mayor Bill de Blasio’s request to start using vaccine doses that have been reserved for second doses.
10. Texas administered more than 150,000 vaccinations on Thursday, the highest 24-hour total since the rollout, Governor Greg Abbott reported, who added that the aggregate figure for shots in the second-largest state will exceed 3 million “in a few days”.
11. US Capitol Police has secured enough doses of the vaccine to vaccinate all of the department’s personnel, acting chief Yogananda Pittman said Thursday, news that comes after more than three dozen employees tested positive in the wake of the January 6 attack on the Capitol.

US Restrictions & Schools

1. Arkansas said it would not extend a directive requiring bars and restaurants selling alcohol to close at 11PM.
2. Massachusetts will increase the capacity on business like restaurants and gyms to 40% from 25%.
3. Michigan will allow high school sports leagues to restart practices and competitions, with masks required.
4. Rhode Island is allowing weddings to have as many as 50 guests, and indoor dining now can include two households.
5. Wisconsin Governor Tony Evers issued a new emergency mask mandate Thursday, minutes after the legislature repealed his previous order, which had been in place since August.
6. Puerto Rico will shorten its nighttime curfew by an hour - the new schedule is midnight to 5AM - and allow many businesses to operate at 50% capacity.
7. Denver began accepting applications for a program that encourages businesses to add Covid-19 safety measures “beyond what is already required by public health orders,” the city government announced, and “In doing so, businesses will be able to expand operational capacity, which will help Denver’s economy recover.”
8. As the debate continues over how to safely bring America's kids back to school, 24 states plus Washington, DC, are now allowing all or some teachers and school staff to receive the vaccine.
9. A pilot project in which rapid tests were used in an effort to safely reopen some US schools has encountered administrative and logistical hurdles, according to a report released Thursday by the Department of Health and Human Services and the Rockefeller Foundation.
10. With a federal transportation mask mandate now in effect, several airlines are adjusting their pre-boarding and pre-departure announcements to remind travelers that they are required to wear face coverings.

Business Related

1. Senator Mitt Romney will propose providing at least $3,000 per child to millions of American families, lending bipartisan support to President Biden’s push to dramatically expand child benefits.
2. Amtrak, the country’s passenger railroad, is spending $3 million in cash bonuses to encourage workers to get a vaccine, an effort to speed protection of its workforce and passengers.
3. Bleach maker Clorox raised its full-year earnings and revenue forecasts as the pandemic continued to fuel demand for cleaning and disinfecting products, and the company now expects fiscal 2021 organic sales between 10% to 13% growth, compared with a prior estimate of a 5% to 9% increase.
4. Yum Brands topped Wall Street’s fourth-quarter earnings and revenue estimates although dining-room closures slowed the recovery in its international markets, reporting fourth-quarter net income of $332 million, or $1.08 per share, as net sales rose 3% to $1.74 billion, with Taco Bell the only brand to see positive same-store sales growth during the quarter.
5. Peloton posted its first $1 billion quarter as consumers stayed inside and worked out at home, a 128% revenue growth from the same period a year prior.
6. Pinterest reported revenue growth of 67% year over year in the US and 145% year over year internationally, as users turned to social media for entertainment.
7. Canada has extended its ban on cruise ships in its waters until March 1, 2022.