WASHINGTON (AP) — The U.S. gave the final go-ahead Friday to the nation’s first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.

Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.

Initial doses are scarce and rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of a long, grim winter. It will take months of work to tamp down the coronavirus that has surged to catastrophic levels in recent weeks and already claimed 1.5 million lives globally.

While the FDA decision came only after public review of data from a huge ongoing study, it has also been dogged by intense political pressure from the Trump administration, which has accused the agency of being too slow and even threatened to remove FDA chief Stephen Hahn if a ruling did not come Friday.

The move sets off what will be the largest vaccination campaign in U.S. history — but it also has global ramifications because it’s a role model to many other countries facing the same decision.

It offers the ability “in this situation where the pandemic is out of control, to bring hope to the people,” Dr. Ugur Sahin, CEO of BioNTech, told The Associated Press.

The world desperately needs multiple vaccines for enough to go around, and the Pfizer-BioNTech shot is the first based on rigorous scientific testing to emerge from that worldwide race — a record-setting scientific achievement that shaved years off the usual process.

“I don’t think you would have found a scientist on this planet that would have predicted this 11 months ago,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia who advises the FDA.

The U.S. is considering a second vaccine, made by Moderna Inc., that could roll out in another week. In early January, Johnson & Johnson expects to learn if its vaccine is working in final testing.

Europe is set to make its own decision on the Pfizer-BioNTech and Moderna shots later this month, an important step as some other candidates that multiple countries were anxiously awaiting have hit roadblocks. Friday, Sanofi and GSK announced a months-long delay after early tests showed their vaccine didn’t work well enough in older adults.

And China and Russia didn’t wait for final-stage tests before beginning vaccinations with some homegrown shots.

President Donald Trump said late Friday that Pfizer had “passed the gold standard of safety,” in a video statement hailing the vaccine as “one of the greatest scientific accomplishments in history.”

About 3 million doses of the vaccine are expected in the first shipments around the country, according to officials with Operation Warp Speed, the Trump administration’s vaccine development program. A similar amount is to be held in reserve for those recipients’ second dose.

The government still is hammering out final recommendations, but expected to follow health workers and nursing homes are other essential workers, older adults and people at high risk because of other health problems. U.S. authorities don’t expect enough for the general population before spring, and that’s assuming there are no manufacturing glitches.

“We would need at least until March, April, to have an impact on the pandemic,” Sahin said. But he predicted that protecting the most vulnerable could start putting a dent in hospitals and deaths sooner.

In a still unfinished study of nearly 44,000 people, the FDA found the vaccine was safe and more than 90% effective across recipients of different ages, including older adults, races and those with health problems that put them at high risk from the coronavirus. It’s authorized for people age 16 and up.

Emergency use means the vaccine still is experimental. Most important for would-be recipients to know:

–Some protection begins after the first dose, but it takes a second dose three weeks later for full protection. It’s unclear how long protection lasts.

—The vaccine protects against COVID-19 illness, but no one yet knows if it can stop the silent, symptomless spread that accounts for roughly half of all cases. The ongoing study will attempt to answer that but for now, the vaccinated still will need to wear a mask and keep their distance.

—Expect a sore arm and some flu-like symptoms such as fever, fatigue, headache and chills after the second dose. While uncomfortable, those reactions only last about a day. “That’s just your immune system working. It’s a good thing,” Offit said.

—Authorities are investigating several allergic reactions reported in Britain by health workers with a history of severe allergies. The FDA said people must have treatments for allergic reactions on hand before they are administered the COVID-19 vaccine, and not give it to those with a known history of severe allergic reactions to any of its ingredients.

—Every vaccine recipient must be given an FDA-written fact sheet about the vaccine and its known risks and benefits.

—FDA didn’t forbid the vaccine’s use in pregnant women but noted there isn’t enough evidence to determine its safety in that group.

If emergency use of Moderna’s vaccine also is authorized, the U.S. expects to vaccinate 20 million people by the end of December. They hope to have enough for another 30 million people in January and 50 million in February.

Globally, Sahin said production should scale up considerably in February, with the companies projecting 120 million to 130 million doses a month to reach 1.3 billion doses in 2021.

Getting shots into arms is the big challenge, especially as a new poll from The Associated Press-NORC Center for Public Affairs Research found only half of Americans want the vaccine when it’s their turn. About a quarter say they won’t get it and the rest aren’t sure.

Political interference has complicated health authorities’ message that the testing was rigorous and cut no corners.

Trump bashed the FDA, again, Friday for taking too long, complaining that the agency “is still a big, old slow turtle.” One of his deputies even pressed Hahn to clear the shots by the end of the day or face possible firing, two administration officials said.

The FDA is unique in analyzing drugmakers’ raw data, a process that takes longer than many other countries’ regulatory reviews. In addition, the FDA insisted that large COVID-19 vaccine studies track at least half the participants for two months to look for side effects, a time period when historically any vaccine problems appear.

Texas’ unhinged bid to overturn the election results in four battleground states will end not in a bang, but a whimper.

Continue reading “SCOTUS Shoots Down TX Election Reversal Gambit Praised By Trump As ‘The Big One’” →

With some Americans now paying the price for what they did over Thanksgiving and falling sick with COVID-19, health officials are warning people — begging them, even — not to make the same mistake during the Christmas and New Year’s season.

“It’s a surge above the existing surge,” said Ali Mokdad, a professor of health metrics sciences at the University of Washington in Seattle. “Quite honestly, it’s a warning sign for all of us.”

Across the country, contact tracers and emergency room doctors are hearing repeatedly from new coronavirus patients that they socialized over Thanksgiving with people outside their households, despite emphatic public-health warnings to stay home and keep their distance from others.

The virus was raging across the nation even before Thanksgiving but was showing some signs of flattening out. It has picked up steam since, with new cases per day regularly climbing well over 200,000.

The dire outlook comes even as the U.S. stands on the brink of a major vaccination campaign against COVID-19, with the Food and Drug Administration expected to give the final go-ahead any day now to use Pfizer’s formula against the scourge that has killed over 290,000 Americans and infected more than 15.6 million.

On Friday, White House chief of staff Mark Meadows pressed FDA chief Stephen Hahn to grant authorization by the end of the day or face possible firing, according to two administration officials speaking on condition of anonymity.

President Donald Trump, who has been fuming at the FDA for not moving faster on the vaccine, called the agency a “big, old, slow turtle” on Twitter, adding: ”Get the dam vaccines out NOW, Dr. Hahn. Stop playing games and start saving lives.”

Hahn has said he would be guided by “science, not politics.”

COVID-19 deaths in the U.S. have climbed to a seven-day average of almost 2,260 per day, about equal to the peak seen in mid-April, when the New York City area was under siege. New cases are running at about 195,000 a day, based on a two-week rolling average, a 16% increase from the day before Thanksgiving, according to an Associated Press analysis.

In Washington state, contact tracers counted at least 336 people testing positive who said they attended gatherings or traveled during the Thanksgiving weekend. More are expected.

The virus could still be incubating in someone who was exposed while traveling home the Sunday after Thanksgiving; the end of that two-week incubation period is this Sunday.

Zana Cooper, a 60-year-old cancer survivor in Murrieta, California, tested positive for COVID-19 after attending a Thanksgiving dinner with her son’s girlfriend’s family. At the dinner, the girlfriend’s father, who had recently traveled to Florida, wasn’t feeling well and went to bed early.

Cooper learned the following Sunday that he tested positive.

“My first reaction was the f-word. I was so mad,” she said. “I was upset. I was angry. I was like, ‘How dare you take my life in your hands?’”

She has had fever and headaches, a runny nose and bloodshot eyes, and in recent days it has become more difficult to breathe and she has been using an inhaler. She said she believes she brought the virus home to her daughter and two grandchildren, who live with her and are now ill with what a doctor diagnosed as COVID-19.

In Philadelphia, a woman in her 20s gathered with 10 relatives on Thanksgiving, though she didn’t feel well the day before. She later tested positive for COVID-19. Her family started developing symptoms, and seven members tested positive, said Philadelphia Health Commissioner Dr. Thomas Farley.

The next round of festivities could yield even more cases. Wall-to-wall holidays started this week. Hanukkah began Thursday evening and ends Dec. 18, followed by Christmas, Kwanzaa and New Year’s Eve.

“This is not the time to invite the neighbors over for dinner. This is not the time to start having parties,” said Arizona State University researcher Dr. Joshua LaBaer.

In parts of New York state, contact tracers are regularly hearing from the newly infected that they attended Thanksgiving festivities, said Steuben County Public Health Director Darlene Smith. Still unknown is how many they will infect and how many eventually will need a bed in intensive care, she said.

“It’s the domino effect,” Smith said.

Harry and Ashley Neidig, of Shepherdstown, West Virginia, tested positive for COVID-19 last week. They said they believe they contracted it from someone at their jobs as security officers but didn’t know of their possible exposure before they celebrated Thanksgiving with both sides of the family.

On the Tuesday after Thanksgiving, Ashley Neidig, 25, noticed she couldn’t smell a menthol-scented body scrub. After the couple got tested, they contacted their families to warn them. Some were awaiting test results, and so far no one else has had any symptoms, said Harry Neidig, 24.

“We feel bad because … we definitely should’ve put a heavier weight into our decision to go,” he said. “We should have told our family, ‘Hey, given the nature of our job, we can’t quarantine like other people in an office job.’”

He added: “You might want to take another look before you go somewhere for Christmas.”

The surge around the country has swamped hospitals and left nurses and other health care workers exhausted and demoralized.

“Compassion fatigue is the best word for what we’re experiencing,” said Kiersten Henry, an ICU nurse practitioner at MedStar Montgomery Medical Center in Olney, Maryland. “I feel we’ve already run a marathon, and this is our second one. Even people who are upbeat are feeling run down at this point.”

While some hospitals are scrambling to find beds and convert storage rooms and other places for use in treating patients, they are also dealing with dire staff shortages.

“We know how to make new beds,” said Dr. Lew Kaplan, a critical care surgeon at the University of Pennsylvania’s Perelman School of Medicine. “We don’t know how to make new staff.”