July 28, 2021 US coronavirus news

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, and a board member at Pfizer, said that when it comes to full approval of Covid-19 vaccines, much of what the FDA is now doing is going through the portion of the application that deals with manufacturing. 

A lot of what the FDA is now doing is going through what is called the CMC – chemistry, manufacturing and controls – portion of the application, he said.  

“Basically, the portion of the application that deals with the manufacturing of the vaccines so that they can put appropriate language and labeling on what the storage and handling requirements going to be for the vaccine when it’s put into general distribution, because remember we’ve been distributing the vaccine through special vaccine distribution sites,” he said, adding that once the vaccine is fully approved, it gets put into normal distribution so there has to be information on appropriate handling and shelf life.

A lot of the clinical portion of the review has probably already been done because the information has been going to FDA on a rolling basis and it has been evaluating the clinical performance all the way through. 

“I think that you’re going to see these get fully licensed, but the reality is the bulk of the work, and what people think of in terms of the core of the application, the clinical data, a lot of that’s already been reviewed, the agency has gotten comfort around that, in my estimation,” he said. 

The Baltimore Ravens opened training camp on Wednesday without starting quarterback Lamar Jackson, after the former league MVP tested positive for Covid-19.

Ravens head coach John Harbaugh confirmed Jackson and running back Gus Edwards tested positive for Covid-19 after the team’s practice, “We had Gus Edwards for Covid and Lamar Jackson tested positive for [Covid-19]. Those two guys will be put in the protocol, and that's really the extent that we can comment on those two guys at this time.”

Per NFL health and safety protocols, vaccinated players who test positive and remain asymptomatic are eligible to return after testing negative twice in a 24-hour span. Unvaccinated players are required to quarantine for 10 days and then test negative in order to return. 

It is unclear if Jackson is vaccinated. In June, Jackson was asked about his vaccination status saying, “Just like everyone in society, it’s their decision, keeping that to themselves, but I feel we do a great job here of taking the vaccine, staying away from Covid, following the right preparation and stuff like that, staying away from the outside to the people that are attracting it.” 

CNN has inquired about Jackson’s vaccination status.

Last November, the Ravens struggled to manage a coronavirus outbreak within the team - at one point placing over 20 players on the team's Reserve/Covid-19 list.

On Wednesday, the NFL disclosed their latest update on player vaccination percentages. The league says 86.9% of players are vaccinated overall (at least one shot) with 18 clubs with over 90% vaccinated.

Several Republicans in the House, including Minority Whip Steve Scalise are openly blasting a new mandate that members in the House must mask up again due to the increase in Covid-19 cases arising from the much more transmissible Delta variant. 

GOP Rep. Lauren Boebert threw a mask back at a floor staffer when she was offered one while trying to walk onto the floor maskless, according to a witness account relayed to CNN. Her office later released a statement saying: “Rep. Boebert refuses to comply with Speaker Pelosi’s anti-science, totalitarian mask mandate. When offered a mask, she returned it with a quick slide across the table.”

Boebert then sat on the House floor without wearing a mask, the only member on the floor not to be wearing one.

GOP Rep. Chip Roy, later entered the floor maskless, and called for the House to adjourn. Fellow Freedom Caucus members, Marjorie Taylor Greene, Andy Biggs and Boebert then stood up and yelled AYE also all not wearing masks, but Democrats opposed.

Roy and Boebert’s actions come one day after the House reinstated its mask mandate.

Members found not wearing a mask are subject to a $500 fine, per House rules. The House's mandate follows the US Centers for Disease Control and Prevention's new recommendation Tuesday that all Americans should mask up indoors, regardless of vaccination status, in areas with "high" or "substantial" Covid-19 transmission. 

GOP Rep. Chip Roy joined Rep. Lauren Boebert in refusing to wear a mask on the House floor Wednesday, calling the newly reinstated rules “patently absurd.”

When asked if he has any intentions of masking up in the Capitol, Roy told CNN “we’ll see.”

Rep. Marjorie Taylor Greene also walked onto the floor this morning without a mask. CNN asked her if she was going to wear one. She said: “Do you see a mask on my face? I think that’s the answer to your question. And I’m suing Nancy Pelosi for violating the 27th amendment.”

Separately, Scalise responded on Twitter to the latest change in mask guidance, writing, "This isn't about science—it's about government control."

"First they told us don’t wear a mask. Then they told us wear a mask. Then wear two masks. Then get the vaccine and you don’t have to wear a mask. Now they tell us never mind, wear a mask. This isn't about science—it's about government control," Scalise wrote on Twitter.

Scientists argue best practices and mandates will continue to evolve as the science and the virus evolves. 

New York Gov. Andrew Cuomo is ordering all patient-facing healthcare workers in state hospitals to get vaccinated with no testing option. He made the announcement while speaking at a virtual meeting for The Association for a Better New York.

“We need dramatic action to get control of this situation,” Cuomo said. “We want to make sure that those healthcare workers are vaccinated. Period.”

Cuomo also said that the state is conducting a full review of the new CDC guidance suggesting masks indoors for everyone, included those who are vaccinated, in areas with substantial Covid cases. 

Cuomo added that New York will follow President Biden’s planned announcement that all federal workers be vaccinated or get tested. New York state workers fill need to do the same, effective Labor Day, which is Sept. 6.

“We're working with our unions to implement this quickly and fairly, but we want to get it done by labor day and I encourage all local governments to do the same,” Cuomo said.  

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration said the US isn’t doing a good job of measuring how much spread is happening in the country and there is probably a lot more than is being picked up. 

The US is not doing a lot of testing, he said, and much of the testing done is at home and not being reported. Many people who are getting infected now or experiencing mild symptoms are not seeking out tests.

“Generally speaking, the people who are presenting for testing are either people who are getting very sick, or people who are developing telltale symptoms of Covid like loss of taste or smell,” he said. “So, we’re picking up probably a very small fraction of the overall infections.”  

At the height of the epidemic in winter, 1 in 3 or 1 in 4 infections were probably diagnosed; last summer, probably 1 in 10 were being diagnosed, Gottlieb said: “I wouldn’t be surprised if we’re only turning over one in ten infections right now, maybe less than that.” 

“If you start to impute that and you factor in how many people remain unvaccinated and vulnerable to this infection, it’s about maybe 80 million Americans that are unvaccinated and remain vulnerable to infection,” he said. “Probably a lot of them have now been infected with this Delta wave, we probably have a lot more infection in the states with vaccination rates are low than what we’re picking up.” 

The biggest part of the problem, he said, is that there aren’t solid numbers saying this is true. 

“CDC has a retrospective mindset in terms of how they operate, they really don’t have a prospective mindset. They don’t do real-time forecasting, and they don’t collect all the data that’s necessary to make real-time decision making,” Gottlieb said.

In a response to CNN on Wednesday, CDC did not address whether cost was a factor in how it’s tracking breakthrough cases. It noted that in early May, CDC transitioned to focus on breakthrough cases in patients who were hospitalized or die. 

“This shift will help maximize the quality of the data collected on cases of greatest clinical and public health importance,” CDC’s Jasmine Reed said in an email, adding, “State and local health departments continue to report breakthrough cases to CDC to identify and investigate patterns or trends among hospitalized or fatal vaccine breakthrough cases.”

Kenya is set to receive 2,460,000 Covid-19 vaccine doses through bilateral donations from the US and European countries, according to the Ministry of Health. 

Kagwe said the vaccine doses will start arriving in the country at the beginning of next week in a boost to the ongoing vaccination campaign. The current drive has seen 1,692,793 of the 1,733,100 AstraZeneca doses received in the country administered.

Kenya’s Ministry of Health added in a tweet that the COVAX initiative has also allocated Kenya 407,040 doses of the AstraZeneca vaccine and 271,440 doses of the Pfizer vaccine. Those doses are in addition to the government-procured 13 million doses of the Johnson & Johnson vaccine, whose delivery will start next month.

In preparation for the arrival of the Pfizer vaccines, which require ultra-cold storage at -70 degrees, the cabinet secretary said, “Kenya will be receiving 15 ultra-cold chain freezers from the UPS Foundation valued at 15 million shillings ($138,100) within the next two weeks.” These will be delivered to the main vaccine store in Kitengela, along with nine of the regional stores across the country allowing a shelf-life of six months.

The Kenya Ministry of Health said it "will work with county governments to conduct outreach services aimed at increasing demand for vaccine services among priority populations and hard to reach areas."

The department said the latest initiative remains in line with President Uhuru Kenyatta’s plan to have 10 million people vaccinated by Christmas this year, with the entire adult population of 26 million to be done by end of next year in an effort to reach herd immunity.

The statement comes as the White House National Security Council’s Senior Director for Africa Dana Banks announced the US will be sending more than 5 million doses of the Pfizer vaccine to South Africa, and just over 4 million doses of the Moderna vaccine to Nigeria.

General Motors and Ford tell CNN that they have reinstated mask mandates at some of their US facilities.  

General Motors spokesperson Dan Flores said they reinstated mandatory mask wearing at their Wentzville, Missouri, assembly plant, "based on a recommendation from GM’s Medical team review of positive cases in the community, absentee rate, local infection rates, etc." The mandate went into effect prior to the new CDC guidance was announced on Tuesday afternoon.

Ford spokesperson Daniel Barbossa told CNN that they would be requiring face masks for all employees and visitors in their facilities in Missouri and Florida.  

Barbossa also said that the company is requiring that employees be fully vaccinated for Covid-19, "prior to any international business travel due to the potential of increased exposure to COVID-19."

Both companies say they are strongly encouraging all employees get vaccinated against Covid-19.

New York City Mayor Bill de Blasio said the city’s health officials are reviewing the new CDC guidance on indoor masking and will have more to say on it in the upcoming days. 

“We are accessing the new information from the CDC right now, we got it less than 24 hours ago. It is complicated information, so our health team is reviewing it and we’ll have more to say on it in the next few days,” de Blasio said during an ongoing press conference Wednesday. 

All five boroughs in New York City are indicated as areas of high or substantial risk of Covid-19 spread and would fall under the CDC guidelines for indoor masking.

The Department of Homeland Security is requiring all federal employees, contractors, and visitors to wear a mask inside all DHS workspaces and federal buildings as of Wednesday, according to a memo sent to the workforce.

Masks are mandated across the United States, regardless of vaccination status or level of Covid-19 transmission in the local area. 

The memo, sent late Tuesday night from DHS Deputy Under Secretary for Management Randolph “Tex" Alles, urges employees to get vaccinated and get tested for Covid-19 if they experience symptoms. 

Alles told employees and contractors to "continue to physically distance" and follow workplace protection guidance.

The memo was shared with the workforce several hours after the department announced Homeland Security Secretary Alejandro Mayorkas will work virtually this week after exposure to a DHS employee who tested positive for Covid-19, according to a department spokesperson.

"The Secretary has no symptoms and has tested negative twice. Official DHS contact tracing is underway," DHS Assistant Secretary for Public Affairs Marsha Espinosa said in a statement Tuesday.