Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter.
The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.
The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.
“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.
With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.
“Help is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease expert said on the eve of Pfizer’s announcement, adding that it’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.”
Friday’s filing would set off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.
How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart.
Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks.
Here’s what happens next:
MAKING THE DATA PUBLIC
The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.
So far, what’s known is based only on statements from Pfizer and BioNTech. Of 170 infections detected to date, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot. On the safety side, the companies cites results from 38,000 study participants who’ve been tracked for two months after their second dose. That’s a milestone FDA set because historically, vaccine side effects don’t crop up later than that.
“We’ll drill down on these data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.
Think of it like science on trial. A few days before the meeting, the FDA will release its own internal analysis. That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.
They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom. For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?
There’s still no guarantee. “We don’t know what that vote’s going to be,” said former FDA vaccine chief Norman Baylor.
EMERGENCY USE ISN’T THE SAME AS FULL APPROVAL
If there’s an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.
That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.
There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?
That’s why the 44,000-person study needs to keep running -- something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.
And at least for now, pregnant women won’t qualify because they weren’t studied. Pfizer only recently began testing the vaccine in children as young as 12.
A decision on Pfizer’s vaccine won’t affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.
Brewing vaccine is more complex than typical drug manufacturing, yet the millionth dose to roll out of Pfizer’s Kalamazoo, Michigan, factory must be the same purity and potency as every dose before and after.
That means the FDA decision isn’t just based on study data, but on its determination that the vaccine is being made correctly.
The Pfizer-BioNTech vaccine -- and Moderna’s shots -- are made with brand-new technology. They don’t contain the actual coronavirus. Instead, they’re made with a piece of genetic code for the “spike” protein that studs the virus.
That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.
GETTING INTO PEOPLE’S ARMS
Another government group -- advisers to the Centers for Disease Control and Prevention -- decides who is first in line for scarce doses. Health and Human Services Secretary Alex Azar said he hopes that decision can be made at the same time as FDA’s.
The Trump administration’s Operation Warp Speed has worked with states to line up how many doses they’d need to cover the populations offered vaccine first.
Pfizer will ship those supplies as ordered by the states -- only after FDA gives the OK.
Company projections of how much it will ship each month are just predictions, Baylor warned.
“It’s not like a pizza,” he said. Manufacturing is so complex that “you don’t necessarily end up with what you thought.”
A few miles south of the namesake tower where Donald Trump began his run for president, New York prosecutors are grinding away at an investigation into his business dealings that could shadow him long after he leaves office in January.
The probe led by Manhattan District Attorney Cyrus Vance Jr. is one of several legal entanglements likely to intensify when Trump loses power — and immunity from prosecution — upon leaving the White House, reports AP.
Trump faces two New York state inquiries into whether he misled tax authorities, banks or business partners. Two women alleging he sexually assaulted them are suing him. Some Democrats are calling for the revival of a federal campaign finance investigation that appeared to end under U.S. Attorney General William Barr.
It isn’t known whether any investigation has gathered sufficient evidence to charge Trump with any crimes.
Prosecuting a former president would also be an unprecedented step in a country that has sought, since its founding, to sweep aside a departing commander-in-chief’s alleged transgressions in favor of a peaceful transition of power.
“With the country so sharply polarized in 2020, would a legal battle ultimately be seen as political retaliation? That is a difficult calculation,” said Meena Bose, executive director of the Peter S. Kalikow Center for the Study of the American Presidency at Hofstra University.
Trump has said that he has the “absolute right” to pardon himself for any federal offenses, but the concept remains untested because no president has ever attempted to do so. A 1974 Justice Department opinion said presidents could not pardon themselves because that would violate the “fundamental rule that no one may be a judge in his own case.”
Trump has used his pardon power to help out friends and high-profile defendants in the past, commuting the sentence of longtime friend Roger Stone in July and former Illinois Gov. Rod Blagojevich in February, and has suggested he could do more of the same before his term ends.
Vance’s investigation is particularly troublesome for Trump because it involves possible state-level charges that could not be wiped away with a presidential pardon.
Vance, a Democrat, hasn’t disclosed the details of his probe, citing grand jury secrecy rules, but his office has said in court filings that it is related to public reports of “extensive and protracted criminal conduct at the Trump Organization.”
Trump’s former personal lawyer and fixer, Michael Cohen, told Congress that Trump often inflated the value of his assets when dealing with lenders or potential business partners, but deflated them when it benefited him for tax purposes.
While Trump has been in office, the investigation’s progress has been hampered by court fights over whether prosecutors could get access to his tax returns, or whether a president has any immunity from a state investigation. One appeal related to the records battle is now before the U.S. Supreme Court.
Vance’s office declined to comment. It isn’t clear whether the long-running probe is close to conclusion, or months or years away from any resolution.
A message seeking comment was left with a lawyer for Trump. In the past, Trump has called Vance’s investigation “a continuation of the witch hunt — the greatest witch hunt in history.”
New York Attorney General Letitia James is also investigating whether Trump’s company lied about the value of its assets to get loans or tax benefits, though her probe is civil — not criminal — in nature. Trump’s son, Eric Trump, spoke by video with investigators last month after losing a court fight to postpone the deposition until after the election.
There were new revelations Thursday that both James and Vance had also subpoenaed documents related to tax deductions taken by Trump’s company related to business consulting fees paid to his daughter, Ivanka Trump.
Part of Vance’s criminal investigation pertains to payments made during Trump’s 2016 campaign to porn actress Stormy Daniels and model Karen McDougal to prevent them from publicly alleging they had extramarital affairs with him.
Cohen pleaded guilty to orchestrating the payments, which Manhattan federal prosecutors said amounted to illegal gifts to Trump’s campaign. They identified Trump in court filings as having directed Cohen’s efforts, but he was not charged. Trump has denied the affairs and said any payments were a personal matter, not a campaign expense.
The Justice Department has a longtime policy stating that it is unconstitutional to prosecute a sitting president in federal court.
There is also the potential that a Democrat-led Justice Department could pursue matters left uncharged in Robert Mueller’s investigation into Russian election interference, such as allegations Trump obstructed justice.
President-elect Joe Biden, a Democrat, has said that he would not direct his Justice Department to pursue charges against Trump — nor would he stand in the way of investigations it might take up on its own.
“I am not going to make that individual judgment,” Biden told reporters in August.
Some Democrats have cautioned that indicting Trump could enrage the nearly 74 million Americans who voted for him, complicating Biden’s promised effort to heal the nation’s political divisions. Former U.S. Attorney General Eric Holder, a Democrat, has warned of the “potential cost to the nation” from prosecuting a former president.
Richard Nixon was pardoned by his successor, Gerald Ford, after resigning in 1974 over the Watergate break-in in an effort by Ford to end the fallout from an all-consuming political scandal. Bill Clinton, on his final day in office, struck a deal with special counsel Robert Ray to avoid prosecution over perjury allegations that led to his impeachment. He agreed to give up his law license for five years and pay a $25,000 fine for lying in a sexual harassment lawsuit.
Paul Rosenzweig, a former senior counsel in the Clinton investigation, argues that potentially criminal behavior stemming from Trump’s time as a businessman would make him an exception to the practice of not prosecuting former presidents.
“Never before have we had a president, who has been credibly accused of criminal activity from before his presidency,” he said.
Once out of office, Trump won’t be able to point to his busy schedule as a reason to delay civil lawsuits, like ones brought by E. Jean Carroll, a former magazine advice columnist, and Summer Zervos, a restaurateur and contestant on his old TV show, “The Apprentice.”
Carroll says Trump raped her in the mid-1990s in a New York department store. Her lawsuit says Trump’s denial of the allegation — including that she was “totally lying” to sell a memoir — defamed her. Carroll is seeking a DNA sample from Trump to see if it matches material found on a dress she says she wore during the alleged attack.
Zervos says Trump kissed and groped her when she sought to talk to him about her career in 2007. Trump denied her allegations and retweeted a message calling Zervos’ claims a hoax.
Trump’s lawyers have maintained that Zervos’ defamation suit should be delayed until he’s out of office. That’s now only about nine weeks away.
Also read: Why AP called Georgia for Biden
More than two weeks after Election Day, The Associated Press has declared Joe Biden the winner of the presidential contest in Georgia, a longtime Republican state that the Democratic president-elect narrowly won by making major inroads in suburban areas that formerly favored the GOP.
Biden won the presidency on Nov 7, after capturing Michigan, Pennsylvania and Wisconsin, which had swung for President Donald Trump in 2016. But his 0.3 percentage point lead over Trump in Georgia was so narrow that the state could not be called — until now.
It is AP’s practice not to call a race that is — or is likely to become — subject to a recount. While there is no mandatory recount law in Georgia, state law provides that option to a trailing candidate if the margin is less than 0.5 percentage points.
The AP called the race for Biden on Thursday after state election officials there said hand-tallied audit of ballots cast in the presidential race confirmed the former vice president leads President Donald Trump by roughly 12,000 votes out of nearly 5 million counted.
The audit’s review of ballots cast confirmed Biden’s lead, and no available evidence suggests a machine recount of ballots already reviewed by hand will result in a different outcome. Therefore, AP declared Biden the winner in Georgia.
The hand tally completed this week is not legally a recount under Georgia law. Rather, it was the race selected by Secretary of State Brad Raffensperger for review under a new state law that says one race in the general election must be audited by hand to check that machines counted ballots accurately. Raffensperger said the tight margin of the presidential race meant a full hand count of ballots was necessary to complete the audit.
Gabriel Sterling, who oversaw the implementation of the state’s new voting system, said the result of the hand audit found Biden leading Trump by a little more than 12,000 votes. Going into the hand tally, Biden led Trump by a margin of about 14,000 votes. Previously uncounted ballots discovered in several counties during the hand count reduced that margin, while other counties found slight differences in results as they did their hand counts. State election officials had consistently said that was to be expected, and stressed the audit was not a response to any suspected problems with the state’s results or an official recount request.
While not formally a recount under the letter of state law, the hand tally conducted to complete the audit was, in practice, a recount.
Also Read- Joe Biden wins Georgia
“Every single vote was touched by a human audit team and counted,” Sterling said.
The state has until Friday to certify results that have been submitted by the counties. At that point, Trump’s campaign has two business days to request a recount. That recount would be done using scanners that read and tally the votes and would be paid for by the state’s counties.
On Election Day, Trump had initially jumped out to an early lead in the state. But Biden did well with voters who cast ballots by mail. And as those ballots continued to be counted in the days after the Nov 3. election, he overtook Trump.
Georgia has long been a Republican stronghold, dominated at most levels of government by the GOP. Voters there hadn’t swung for a Democratic presidential candidate since Bill Clinton in 1992. Trump beat Hillary Clinton there by 5 percentage points in 2016.
But the party’s grip has loosened. As older, white, Republican-leaning voters die, they’ve been replaced by a younger and more racially diverse cast of people, many of whom moved to the booming Atlanta area from other states — and took their politics with them.
Overall, demographic trends show that the state’s electorate is becoming younger and more diverse each year. Like other metro areas, Atlanta’s suburbs have also moved away from Republicans. In 2016, Hillary Clinton flipped both Cobb and Gwinnett counties, which Biden won.
In 2018, Democrat Stacey Abrams galvanized Black voters in her bid to become the country’s first African American woman to lead a state, a campaign she narrowly lost.
Many political analysts say it’s not a question of if, rather when, Georgia becomes a swing state. That much was clear in the closing weeks of the campaign as Biden; his running mate, Sen Kamala Harris; and former President Barack Obama barnstormed the state. Trump, too, visited the state to play defense.
The question that remains is whether Biden’s win marks a major shift, or a temporary revolt by suburban voters who disliked Trump and who will return to the Republican fold after he’s gone.
A Pentagon official installed in a top policy job last week has tested positive for COVID-19, the Pentagon said Thursday, just days after he met with the Lithuanian defense minister, who had contracted the virus.
Jonathan Hoffman, the chief Pentagon spokesperson, said Anthony Tata, who is serving as the undersecretary of defense, was tested Thursday after learning that Defense Minister Raimundas Karoblis had tested positive. Tata and other senior defense leaders, including Acting Defense Secretary Christopher Miller and the secretaries of the Army, Navy and Air Force, all met with Karoblis either last Friday or Monday.
Hoffman said the department is doing contact tracing and conducting rapid testing for those who came in contact with the delegation. Miller and other senior staff and a media contingent traveled Wednesday to meet with troops and leaders at Fort Bragg, North Carolina, and then flew out to the aircraft carrier USS Gerald R Ford, off the coast of Virginia. Video of the visit showed Miller shaking hands and hugging people at Fort Bragg, and he met with sailors on the ship.
Tata is just the latest top Trump administration member to become infected. White House chief of staff Mark Meadows tested positive after attending an election night party at the White House. Others who were at the party also tested positive, including White House political director Brian Jack, former White House aide Healy Baumgardner and Trump campaign advisers David Bossie and Corey Lewandowski. Lewandowski said he believed he contracted the virus in Philadelphia while assisting the president’s election challenge there.
Trump himself was treated at Walter Reed National Military Medical Center in October when he contracted the virus. Others in Trump’s orbit who have tested positive include his wife, Melania, his son Barron, press secretary Kayleigh McEnany and advisers Stephen Miller and Hope Hicks.
There also was an outbreak at the Pentagon last month when Admiral Charles W Ray, the vice commandant of the Coast Guard, found out had he tested positive after meeting in the Pentagon with members of the Joint Chiefs of Staff. The assistant commandant of the Marine Corps later also tested positive, and all the chiefs were forced to quarantine at home for at least 10 days.
Hoffman said in a statement that the department has recently “recommitted to fastidiously following the CDC guidelines with respect to mitigation measures — face coverings, social distancing, contact tracing, hand washing and virtual engagements among others.”
Hoffman said Miller and the service secretaries aren’t going to quarantine “based on testing and mitigation measures that were in place during the Lithuanian delegation’s visit and CDC guidelines.”
Tata, a former Fox News commentator and retired one-star general, was moved into the top policy job just a few months after he failed to get through Senate confirmation because of offensive remarks he had made, including about Islam.
He is performing the duties of the undersecretary of defense for policy. James Anderson, who had been acting undersecretary, resigned last week, shortly after President Donald Trump fired Defense Secretary Mark Esper and named Miller the acting Pentagon chief.
Joe Biden has won Georgia and its 16 electoral votes, an extraordinary victory for Democrats who pushed to expand their electoral map through the Sun Belt.
The win by Biden pads his Electoral College margin of victory over President Donald Trump. Biden was declared the winner of the presidential election on Nov 7 after flipping Pennsylvania, Michigan and Wisconsin to the Democrats’ column.
Biden now has 306 electoral votes to Trump’s 232.
Also Read- Biden wins White House
Trump won Georgia by 5 percentage points in 2016 over Democrat Hillary Clinton.
In 2020, Democrats had focused heavily on the state, seeing it in play two years after Democrat Stacey Abrams narrowly lost the governor’s race. Both of Georgia’s Senate seats were on the ballot this year, further boosting the state’s political profile as well as spending by outside groups seeking to influence voters. Those two races are headed to a January runoff.
Georgia hadn’t voted for a Democratic presidential candidate since Bill Clinton in 1992.