CDC gives final approval to Pfizer vaccine; first shipments roll out; inoculations could start Monday


A small crowd cheered as semi-trucks rolled out of the loading dock at a Pfizer manufacturing plant in Kalamazoo, Michigan, on Sunday, beginning historic journeys to deliver insulated boxes of the nation’s first COVID-19 vaccine to hospitals and health departments across America.

Hours later, the Centers for Disease Control and Prevention formally announced that it had the Advisory Committee on Immunization Practices’ recommendation of the first authorized coronavirus vaccine for people 16 years and older. Healthcare personnel and long-term care facility residents should be vaccinated first.

Earlier, the caravan of FedEx, UPS and Boyle Transportation trucks accompanied by unmarked police cars pulled out of the parking lot about 8:25 a.m., headed to airports and distribution centers. Pfizer has said it will deliver 6.4 million doses in this initial shipments. Federal officials say they will be staggered, arriving in 145 distribution centers Monday, with an additional 425 sites getting shipments Tuesday, and the remaining 66 on Wednesday.

Army Gen. Gustave Perna of Operation Warp Speed, the Trump administration’s vaccine development program, said vaccines should arrive at many sites early Monday. The first inoculations could come that day.

The vaccine is offering hope in the fight against the pandemic that has killed nearly 300,000 in the U.S. alone. But it will take months to produce and distribute enough to vaccinate most Americans, and experts warn that infections, hospitalizations and deaths will likely climb this winter.

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Here are today’s top headlines:

  • An advisory committee to the Centers for Disease Control and Prevention voted Saturday to recommend the Pfizer/BioNTech vaccine for people 16 and older. Now it goes to the director of the CDC for his signature.

  • The Food and Drug Administration late Friday granted emergency use of the vaccine

  • The U.S. has recorded more than 16 million cases of COVID-19, by far the most of any country in the world

  • About 1 in 8 U.S. hospitals had few or no intensive care unit beds available last week, according to new federal data. Experts say the number of hospitals struggling to accommodate the nation’s sickest patients likely will increase following another week of record COVID-19 cases.

📈 Another day of record deaths in the US: As of Sunday, almost 300,000 people in the U.S. have died, with more than 16 million confirmed cases, according to Johns Hopkins University data. The global totals: more than 70 million cases and 1.6 million deaths.

📰 What we’re reading: We’re answering your questions about the vaccine, like: What are the side effects? Can you still get sick? Is it safe during pregnancy? Read more here.

No surprise: CDC chief Redfield signs off on Pfizer vaccine

The Pfizer coronavirus vaccine quietly cleared it last U.S. hurdle when the Centers for Disease Control and Prevention announced Sunday that director Robert Redfield had given a green light to mass use of the vaccine. Redfield’s perfunctory decision came after the Advisory Committee on Immunization Practices gave it’s ok to the vaccine for people 16 and older. The FDA also has authorized emergency use of Pfizer’s vaccine. CDC approval comes at a “critical time,” Redfield said.

“Initial COVID-19 vaccination is set to start as early as Monday,” he said. “This is the next step in our efforts to protect Americans, reduce the impact of the COVID-19 pandemic, and help restore some normalcy to our lives and our country.”

Pfizer, Chinese vaccine gain acceptance among Persian Gulf states

Kuwait granted emergency use for the Pfizer vaccine but faces an uphill battle in efforts to convince its population to get vaccinated. A survey done by Kuwait’s Al Qabas news agency showed 46% of Kuwaitis refuse to take the vaccine, while just 39% said they would take it. Another 15% said they were not sure. Health officials said they hope to obtain some of the vaccine by month’s end.

Kuwaiti neighbor Bahrain, which previously had signed off on the Pfizer vaccine, said Sunday it has approved the Chinese coronavirus vaccine that won approval in the United Arab Emirates last week.

First vaccines won’t slow surge in deaths; 500,000 are possible

The U.S. was hurtling Sunday toward the once-unthinkable threshold of 300,000 COVID-19 deaths – even with vaccines on the way. A weeks-long surge in coronavirus transmission across the nation has fueled an average of more than 210,000 new infections and nearly 2,500 deaths a day this month. According to Johns Hopkins University data, the U.S. had recorded 297,886 coronavirus deaths as of 12:30 p.m. ET on Sunday.

Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, has warned the country could reach 450,000 fatalities before Feb. 1, days short of the one-year anniversary of the first known COVID-19 death in the U.S. Dr. John Swartzberg, a professor emeritus of infectious diseases and vaccinology at the University of California-Berkeley, says even that number could be conservative.

“The way the number of infections has been growing so fast, it’s hard to believe we won’t be at half a million deaths,’’ Swartzberg said.

Jorge L. Ortiz

States, cities gearing up:

  • In New Jersey, one of the worst-hit states, health care workers at University Hospital in Newark will become the state’s first vaccine recipients on Tuesday, Gov. Phil Murphy said. The state has absorbed almost 18,000 deaths.

  • Rhode Island officials said they expect the vaccine to arrive at some hospitals Monday and Tuesday. A panel of independent advisers will hold an emergency meeting at 7:30 a.m. Monday to consider recommending that hospitals start vaccinating frontline staff immediately, officials said.

  • In North Carolina, some hospitals were hoping to start administering the vaccine Monday morning – assuming they receive their shipments promptly and have enough time to adequately train staff, officials said.

  • Mayor Bill de Blasio pledged the vaccine will be distributed equitably in New York City, saying it must reach the people of color who have “disproportionately suffered from the coronavirus and therefore need the vaccine the most.”

FDA chief’s says he hopes first vaccinations take place Monday

Food and Drug Administration Commissioner Dr. Stephen Hahn said Sunday that his “greatest hope” that the nations first coronavirus coronavirus vaccinations take place Monday. A first shipment of vaccination doses should arrive Monday in every state, he said.

“Well, my hope, again, is that this happens very expeditiously, hopefully tomorrow,” Hahn told CNN’s State of the Union. “It would be my greatest hope and desire that that occur tomorrow.”

Hahn also denied claims that he was ordered by the White House to approve the vaccine on Saturday or he would be forced to resign.

“There was a desire for us to move as quickly as possible,” he said. “We have.?

Can vaccinated Americans spread COVID? Experts still are not sure

It is not yet clear whether someone who is vaccinated could still acquire the virus without any symptoms and potentially be contagious to others, the director of the National Institutes of Health said Sunday. Dr. Francis Collins said the “urgent question” will take months to answer.

“What that means is if you’ve had the vaccine … you still need to think of yourself as potentially contagious,” Collins said on NBC’s Meet the Press. “Masks are still going to be part of our life. We need to recognize that and not step away or start to drop our guard.”

How long will masks be needed? Collins repeated the recurring theme among experts that 70 to 80% of Americans must be immune before “herd immunity” will protect everyone. “We think we can get there by June” if enough people agree to be vaccinated, he said.

Operation Warp Speed chief dismisses vaccine skepticism

The chief science adviser to Operation Warp Speed, a U.S. effort to get vaccines developed quickly, said Sunday he remains “very concerned” about the skepticism the vaccine is drawing from millions of Americans. Last week, regulators in the U.K. began investigating several severe allergic reactions seen after vaccinations began there. The FDA’s instructions tell providers not to give it to Americans with a known history of such reactions.

“There’s been a confusion between how thorough and scientific and factual the work that has been done is, and the perception that people are thinking that we cut corners,” Slaoui said. “I can guarantee you that no such things have happened, that we follow the science.”

Pfizer vaccine shipments: This is how they do it

Because Pfizer’s vaccine must be frozen at the ultra-cold temperature of minus-94 degrees Fahrenheit or lower for storage, shipping doses to hospitals and public health agencies is a challenge. Pfizer’s first shipments include boxes holding 975 vials of vaccine. The boxes are broken down into five trays that each hold 195 vials. Pfizer created temperature-controlled thermal shippers that use dry ice to maintain ultra-cold temperatures for up to 10 days unopened. The vaccines can be kept safely at 36-46 degrees Fahrenheit for up to 24 hours or at room temperature for no more than two hours after it thaws, the company says.

Kristen Jordan Shamus, Detroit Free Press

‘Disaster plan for education’ sought as students struggle in pandemic

Students are struggling, teachers are stressed, and more schools are online. But there’s still no grand plan to improve online learning. Millions of students attending school virtually are foundering academically, socially and emotionally. And as the pandemic heaves into a winter surge, a slew of new reports show alarming numbers of kids falling behind, failing classes or not showing up at all. The consequences are most dire for low-income and minority children, who are more likely to be learning remotely and less likely to have appropriate technology and home environments for independent study.

“We almost need a disaster plan for education,” said Sonya Thomas, executive director of Nashville Propel, a community group that works with many Black parents in Tennessee.

Erin Richards

Emails reflect one family’s struggles with COVID

The day Frank Malinowski, 59, was admitted to the hospital for treatment of COVID-19, his 36-year-old son, Frank “Keith” Malinowski, began to write emails to his family. Over three weeks in October and November, the virus became a plague on the Malinowski family. It delivered “cheap shots.” It took hostages. And it left them with pain and grief. The family has granted the Akron Beacon Journal, part of the USA TODAY Network, permission to print those emails, which have been lightly edited for clarity and length, in the hopes they can convince others to take the virus seriously as cases and hospitalizations continue to surge. You can read them here.

Jennifer Pignolet, Akron Beacon Journal

Here comes the vaccine – and the scams

Criminal networks are ready to roll out counterfeit versions of approved vaccines, much like fake Gucci bags and Nike sneakers, experts warn. Already, consumer watchdogs are hearing reports of imposters claiming to be Social Security Administration workers in order to get sensitive information from people. Scammers might claim they’re calling to sign the person up to receive their vaccine. As part of the sign-up, the scammer asks for nformation such as your Medicare number, name, address and possibly bank account information, said Jon Miller Steiger, director of the East Central Region for the Federal Trade Commission.

“This is a scam,” Steiger said. “The Social Security Administration will not sign you up to receive a vaccine and will not ask for sensitive information by phone, email or text.”

Susan Tompor, Detroit Free Press

Louisville airport playing crucial role in vaccine shipments

The first shipments of the Pfizer/BioNTech COVID-19 vaccine will arrive today at the Muhammad Ali International Airport to be sorted and shipped out the same day to destinations across the eastern U.S. The ultimate destination: The arms of healthcare workers on the front lines of the fight against the coronavirus. To keep the doses chilled, the UPS Worldport in Louisville has built a “freezer farm” on location with 300 ultra-low temperature refrigeration units that can each store 48,000 vials of vaccines.

“We have millions of doses of this vaccine that are now being shipped to every corner of America, with administration to begin as soon as providers are ready,” said Secretary of Health and Human Services Alex Azar.

Lucas Aulbach, Louisville Courier Journal

Contributing: Kristen Jordan Shamus, Detroit Free Press; The Associated Press

This article originally appeared on USA TODAY: COVID update: First vaccine shipments; inoculations begin Monday



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