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Study shows booster shot after 6 to 12 months likely to provide best protection from COVID-19, Pfizer says

Pfizer and BioNTech have released initial data from a study on booster shots for their COVID-19 vaccine, saying a third dose delivered about six months after the second shot has shown neutralization titers are five to 10 times higher than after two primary doses.

The companies said they expect to publish “more definitive data” soon and submit the Food and Drug Administration “in the coming weeks.”

Pfizer said real-world evidence from Israel showed a decrease in efficacy about six months after people were fully vaccinated.

“While protection against severe disease remained high across the full 6 months, the observed decline in efficacy against symptomatic disease over time and the continued emergence of variants are key factors driving our belief that a booster dose will likely be necessary to maintain highest levels of protection,” Pfizer said in a statement.

MORE: How COVID-19 booster shots could help in global fight against the virus

The FDA and Centers for Disease Control and Prevention released a joint statement Thursday evening pumping the brakes on the need for a booster shot yet, and encouraged people to get vaccinated in general. Less than 50% of the U.S. is fully vaccinated at this time.

“Americans who have been fully vaccinated do not need a booster shot at this time,” the agencies said in the statement. “FDA, CDC, and NIH (National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.”

Additionally, the companies are working on materials with a plan to test a new vaccine construct based on the delta variant — with plans to start clinical trials in August.

“While we believe a third dose of BNT162b2 has the potential to preserve the highest levels protective efficacy against all currently known variants including Delta, we are remaining vigilant and are developing an updated version of the Pfizer-COVID-19 vaccine that uses a new construct based on the B.1.617.2 lineage, first identified in India and also known as the Delta variant,” the companies said in a statement.

“The companies are already producing clinical trial material and anticipate beginning clinical studies in August, subject to regulatory approvals,” Pfizer and BioNTech added.

PHOTO: A health care worker holds a vial of the Pfizer/BioNtech COVID-19 vaccine at Memorial Healthcare System in Miramar, Florida, on Dec. 14, 2020. (Chandan Khanna/AFP via Getty Images)
PHOTO: A health care worker holds a vial of the Pfizer/BioNtech COVID-19 vaccine at Memorial Healthcare System in Miramar, Florida, on Dec. 14, 2020. (Chandan Khanna/AFP via Getty Images)

Moderna, the maker of the only other authorized mRNA vaccine in the U.S., has made similar statements about the need for booster shots in the past.

“Booster shots will be needed as we believe the virus is not going away,” Moderna CEO Stephane Bancel said during a first-quarter earnings call to investors in early May.

MORE: US health agencies will decide if COVID-19 booster shots are needed – not vaccine companies

It will be up to the FDA and the Centers for Disease Control and Prevention to determine if and when booster shots will be allowed, recommended and made available.

“Clearly, the pharmaceutical companies have an economic incentive, particularly the ones who have vaccines that are for profit,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told ABC News in late May. “We want the decision to be made based on public health solely and [not] on economic incentives of the companies.”

ABC News’ Anne Flaherty, Arielle Mitropoulos, Dr. Deepak Ramanathan and Sony Salzman contributed to this report.

Study shows booster shot after 6 to 12 months likely to provide best protection from COVID-19, Pfizer says originally appeared on abcnews.go.com

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Minnesota wildfire doubles in size, creates its own weather

A wildfire in northeastern Minnesota more than doubled in size Tuesday, growing to more than 19,000 acres, after it produced pyrocumulous clouds that generated lightning and even raindrops, fire officials said.

The Greenwood Fire’s growth, most of which happened Monday afternoon, prompted firefighters to leave McDougal Lake, about 80 miles south-southwest of Duluth, officials said. Authorities fear that structures might have been destroyed or damaged.

“We had crews embedded, and as this fire took off, it was quite an effort to communicate with forces on the ground so they could get out,” said federal fire incident spokesman Clark McCreedy.

The pullout was a success, and no injuries were reported. However, downed trees and necessary cleanup mean crews have been unable to assess damage around the lake, McCreedy said.

In addition to the firefighter pullout, 159 dwellings were evacuated Monday, according to an update from the National Wildfire Coordinating Group. Cabins, homes and recreational sites remain under threat, the group said.

Patrick Prochaska, a Minneapolis resident who built a cabin near McDougal Lake in 2012, told NBC affiliate KARE that he watched via security camera as flames mostly bypassed his property Monday, causing minor damage.

“I was feeling very scared,” he said. “At the same time, I could see that it was not doing anything to the house, and it was kind of reassuring.”

The fire in and north of Superior National Forest has mostly performed according to the weather, fire officials said. On Monday, with dry fuel on the ground and temperatures in the high 80s, it was an expanding inferno punctuated by strobes of lightning.

“The winds were drawn into the fire from all directions,” the incident’s fire behavior analyst, Michael Locke, said in a video update Tuesday. “It created what we call pyrocumulous clouds. And really high in the atmosphere … you’d see a thunderstorm, and in fact they went high enough to produce a few sprinkles of rain and even some lightning.”

Temperatures dipped into the mid-70s Tuesday, and the blaze mellowed. “The real story was cloud cover and cooler temperatures,” McCreedy said.

More of the same, and possibly rain, was in the forecast, giving officials hope that they might be able to close the book on an unusually active and dry fire season in Minnesota.

Experts have said climate change has set the stage for extreme weather, including an increase in the frequency and intensity of wildfires in the Northern Hemisphere.

Firefighters — 426 were assigned to the Greenwood event — have been confronted with “prolonged, severe drought,” making parts of Minnesota look like the fire-prone West this summer, McCreedy said.

The Greenwood Fire, which was detected Aug. 15, is believed to have been sparked by lightning.

So far, firefighters have scored no containment, and areas including McDougal Lake, Sand Lake and the Highway 2 corridor have been under mandatory evacuation orders. The federal Boundary Waters Canoe Area Wilderness was closed Saturday “due to active and increasing fire activity, extreme drought, limited resources,” the National Forest Service said in a notice.

Officials set a goal of Sept. 1 for full containment.

“We’re probably going to get more of that moderating weather for the rest of the week,” McCreedy said. “That opens the door for fire crews to make progress on the ground.”

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Hiker survives grizzly bear attack at Denali National Park

A tourist from Indiana was attacked and injured by a grizzly bear at Denali National Park and Preserve in Alaska on Monday night, park officials said.

The 55-year-old tourist, whose name was not released, was hiking alone in dense fog in the Thoroughfare Pass area when a mother bear and multiple cubs charged him from nearby bushes, the National Park Service said in a statement Tuesday.

He had puncture wounds to a calf, his left ribs and his left shoulder, the agency said.

The victim used bear spray that might have cut the attack short, the park service indicated. He walked 1.5 miles to a visitor’s center where “medical personnel” vacationing at Denali treated him as a park bus driver called 911, it said.

The hiker was taken to a medical center near the park before he was transferred to Fairbanks Memorial Hospital, about 120 miles away, park officials said. He was stabilized at the Fairbanks hospital, they said.

“Due to the apparent defensive nature of this attack, there are no plans to locate the bear involved,” the park service said. “Female bears with cubs are naturally defensive of their young, especially when surprised. There is no indication that this bear is unusually dangerous.”

Grizzly bears are federally protected as a threatened species in the lower 48 states. According to the National Wildlife Federation, fewer than 1,500 grizzlies are left in the lower 48, but they thrive, comparatively, in Alaska, where they have a population of about 31,000.

The backcountry area of the attack is closed for one week as a precaution, the park service said.

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House passes John Lewis voting rights bill, sends measure to Senate for tougher fight

House Democrats on Tuesday passed a sweeping voting rights bill named after Rep. John Lewis, D-Ga., the late civil rights icon.

The John Lewis Voting Rights Advancement Act was approved 219-212. All Republicans voted against the legislation.

The bill is part of congressional Democrats’ broader campaign to strengthen voting laws at the federal level to fight restrictive voting laws passed in Republican-led states, such as Texas and Georgia. However, it faces steep opposition in the Senate, where Democrats hold a wafer-thin majority.

The House returned from its recess this week to take up the bipartisan infrastructure bill and a resolution for Democrats’ $3.5 trillion budget package, which includes funding for much of President Joe Biden’s legislative agenda. The procedural motion used to pass the multitrillion-dollar resolution paved the way for the House to vote on the voting rights bill, which was re-introduced last week by Rep. Terri Sewell, D-Ala.

The legislation would require states with recent histories of discrimination to get federal “preclearance” to change their voting laws, which directly addresses the Supreme Court’s 2013 ruling in Shelby County v. Holder. The ruling gutted the preclearance system in the Voting Rights Act of 1965, which civil rights advocates argue was successful in blocking proposed voting restrictions in states and localities with histories of racial discrimination.

House Speaker Nancy Pelosi, D-Calif., said in a statement last week that Congress had “not only an ironclad Constitutional mandate, but a moral responsibility” to pass the bill.

Shortly before its passage, Pelosi said on the House floor that the bill would honor Lewis’ legacy.

“We should have the right to vote and shouldn’t be diminished by anyone. It is unpatriotic to undermine the ability of people who have a right to vote, who have access to the polls,” she said. “As John knew, this precious pillar of our democracy is under attack from one of the worst voter suppression campaigns since Jim Crow.”

It isn’t the first time House Democrats have tackled election law. In March, House Democrats passed the For the People Act, a sweeping bill that seeks to change campaign finance, voting and ethics laws.

The bill would expand access to the ballot box by creating automatic voter registration across the country by registering eligible voters whenever they interact with government agencies, restoring the voting rights of the formerly incarcerated, expanding early voting and modernizing the country’s voting systems.

However, Senate Republicans filibustered the voting rights legislation in June, and the vote to advance an amended version of the For the People Act split along party lines 50-50, short of the 60 votes needed. All Democratic-aligned senators voted to begin debate, and Republicans unanimously voted to block the bill.

Passage of the voting measure was the final vote of the week for the House, whose members are leaving Washington and won’t return until Sept. 20.

Haley Talbot contributed.

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