Pfizer eyes full FDA approval of vaccine

Pfizer's next goal: Full FDA approval

Pfizer and German partner BioNTech have a shot at winning the first full approval from the U.S. Food and Drug Administration for a COVID-19 vaccine since they’ve started the process already.

The two companies say they’ve started a "rolling submission" of data from their studies of the two-dose vaccine, first giving the FDA data from laboratory and human testing. That includes their latest analysis from a key late-stage study that followed the participations for up to six months after they received their second dose. The companies plan to soon submit data on manufacturing quality controls and the factories making the vaccine.

Pfizer Chief Executive Albert Bourla said in a statement that the companies are aiming to win full regulatory approval "in the coming months."

The shot received emergency use authorization from the FDA on Dec. 11. Since then, the companies have delivered more than 170 million doses across the U.S., and many more to other countries that also have authorized emergency use amid the coronavirus pandemic. Such emergency authorizations only last until countries declare an end to the emergency, so the vaccine must undergo a more stringent review by regulators to earn full approval for continued use.

The number of new positives reported today: 122 in Nassau, 169 in Suffolk, 890 in New York City and 2,370 statewide.

The chart below shows the percentages of Long Islanders who have received at least one dose of a COVID-19 vaccine and those who have been fully vaccinated.

Search a map of new cases and view charts showing the latest local trends in vaccinations, testing, hospitalizations, deaths and more.

Positivity rate continues to decline, state says

COVID-19 indicators in New York continued their downward spiral on Friday, with the state marking its 32nd day in a row of declines in its seven-day average for positivity in tests for the virus.

The daily positivity average statewide was 1.22%, the lowest since Oct. 22, Gov. Andrew M. Cuomo said. The seven-day average in the test results from Thursday was 1.53%.

On Long Island, the seven-day average dropped to 1.45%, while in New York City it was 1.44%. Just weeks ago, those two areas regularly had positivity rates above 4%.

"As the COVID-19 numbers improve and more residents get vaccinated, we're reopening our economy and getting New Yorkers back to work," Cuomo said. But he cautioned that people still need to follow virus mitigation measures such as wearing a mask and socially distancing to "finally defeat this COVID beast for good."

Meanwhile, New York City is still using refrigerated trucks to store bodies of coronavirus victims, more than a year after they were first set up as temporary morgues as deaths surged at the height of the pandemic. The city’s medical examiner’s office said Friday that 750 bodies are being kept in long-term storage in refrigerated trailers at a Brooklyn pier while family members sort out plans for their final resting places.

Backstreet's not back, but good news for country fans

Backstreet Boys won’t be back … until 2022. The pop quintet has moved its Northwell Health at Jones Beach Theater concert into next summer. The band's July 9 show, first rescheduled from July 10, 2020, due to the pandemic, was supposed to kick off the 2021 season.

"While this isn’t the update we were hoping for, the safety of our fans and crew is of the utmost importance," the group said in a statement. "If you hang on to your concert ticket, you’ll be getting a very special NFT [non-fungible token]! Stay safe and we’ll see you soon!"

All previously purchased tickets will be honored for BSB’s 2022 show, and available seats ($54.50-$499.50) are currently on sale. Ticket holders unable to attend the new date must go to their point of purchase for refund information.

Meanwhile, country singer/songwriter Dierks Bentley will bring his "Beers On Me" tour with special guests Riley Green and Parker McCollum to Northwell Health at Jones Beach Theater on Sept. 24. This marks the first new booking for Jones Beach’s summer roster that hasn’t been a holdover from 2020 and will as of now serve as the last date on the venue’s calendar.

NY hasn't given out any of its $2.4 billion rent relief

Unlike some of its neighbors such as Vermont, which is sending out its second round of rental assistance, New York State hasn't doled out any of its $2.4 billion in rent relief.

Applications aren’t even available. And they won’t be until the end of the month at best.

"There is $2 billion we’ve gotten from the federal government, and it’s as if it has gone into a black hole," said Ellen Davidson, a staff attorney with Legal Aid New York. "We’re very worried that the application isn’t open yet."

Advocates say they’ve been told the state is trying to make sure when the rental-assistance program goes online, it doesn’t suffer the same frequent crashes that hamstrung the unemployment program last year when the pandemic hit.

That’s certainly reasonable, but other states are ahead of New York, Davidson said, "and it’s getting to a point where we're wondering when the money will go out."

Read more from Newsday's Yancey Roy.

More to know

The cast of "Chicago" is ready to give audiences that old razzle dazzle again as producers announced that performances of the long-running musical will resume on Sept. 14 at Broadway's Ambassador Theatre.

Nassau County officials announced that student ambassadors will be encouraging their peers to get the COVID-19 vaccine, and the Nassau Community College vaccination site will be having several "student days" this month with the goal of vaccinating 500 students per day.

America’s employers added just 266,000 jobs last month, sharply lower than in March and a sign that some businesses are struggling to find enough workers as the economic recovery strengthens.

Indian Prime Minister Narendra Modi faced growing pressure Friday to impose a strict nationwide lockdown, despite the economic pain it will exact, as a startling surge in coronavirus cases that has pummeled the country's health system shows no signs of abating.

The Baseball Hall of Fame is still not planning to allow fans at Derek Jeter’s induction ceremony on July 25 despite New York’s ballparks and arenas increasing capacity for events starting on May 19.

News for you

Like a pub crawl, only prettier. For a few short weeks each spring, the maritime Village of Greenport explodes in a riot of cherry blossoms that rivals Washington D.C.’s, but with a bonus: specially marked "pit" stops to purchase cherry blossom-themed cocktails, sweet treats and gifts. The event was canceled last year due to the pandemic, but it's back with offerings such as the Cherry Gin Fizz — a cocktail of shimmering and changing colors that includes Luxardo cherries. Learn more.

Free milkshakes thanks to Adam Sandler. If you haven't been following along, here's the recap: After a hostess at a Long Island IHOP unknowingly told comedian Adam Sandler he'd have to wait 30 minutes for a table (she didn't recognize him in his coronavirus mask), a TikTok video of the encounter went viral, Sandler made a joke and now, we're all getting free milkshakes for one day at the chain's local restaurants.

Dee Snider's ready to rock again. The lead singer of Twisted Sister, who grew up in Baldwin, is returning to Long Island for a one-time concert event, which will be filmed for a future release. Snider will perform at Stereo Garden in Patchogue to a limited-capacity crowd.

Your weekend plans. There's plenty of events to celebrate Mom and activities for everyone else too this weekend on Long Island, from yoga in a garden to a princess tea party and drive-in movies. Get the details and, of course, observe COVID safety protocols in place.

Plus: It's not too early to start planning your Memorial Day weekend, especially with some events having limited capacity. Here's a guide to what's going on.

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Commentary

Telemedicine is a tool — not a replacement for your doctor's touch. Elisabeth Rosenthal writes for Kaiser Health News:

Earlier in the pandemic it was vital to see doctors over platforms like Zoom or FaceTime when in-person appointments posed risks of coronavirus exposure. Insurers were forced — often for the first time — to reimburse for all sorts of virtual medical visits and generally at the same price as in-person consultations.

By April 2020, one national study found, telemedicine visits already accounted for 13% of all medical claims compared with 0.15% a year earlier. And COVID-19 hadn’t seriously hit much of the country yet. By May, Johns Hopkins’ neurology department was conducting 95% of patient visits virtually compared with just 10 such visits weekly the year before, for example.

COVID-19 let virtual medicine out of the bottle. Now it’s time to tame it. If we don’t, there is a danger that it will stealthily become a mainstay of our medical care. Continue reading