Category: Breaking News

The Food and Drug Administration on Saturday granted emergency authorization to Johnson & Johnson’s COVID-19 vaccine, making it the third vaccine to become available to Americans during the pandemic and the first to only require one dose. The vaccine is authorized to be given to adults who are at least 18 years old. J&J’s COVID-19 vaccine is significantly differs significantly from the vaccines developed by BioNTech SE /Pfizer Inc. and Moderna Inc. both of which received emergency use authorization from the FDA in December. An emergency use authorization is a type of regulatory approval that allows companies and regulators to more quickly bring medical products to market during the pandemic. It is not as rigorous as a full FDA approval.

The J&J vaccine requires one dose, not two, is adenovirus-based and doesn’t use mRNA-based technology, can be stored in normal refrigeration temperatures, and was much less efficacious (50% in populations over 60 years old) in clinical trials than both of the mRNA-based vaccines, which had efficacy rates of about 95% in their Phase 3 clinical trials.

The J&J vaccine had an overall efficacy rate of about 66%, with a slightly higher rate of protection in the U.S. at 72%, according to a FDA analysis of Johnson & Johnson’s clinical-trial data. The efficacy rate increased to about 85% when it came to preventing severe or critical disease among participants in the U.S. “This pandemic is very different from two months ago when other vaccine developers were running their trials and accruing cases. It’s a much more complex milieu at the moment,” Mathai Mammen, global head of research and development for J&J’s pharmaceuticals business, said in January, according to a FactSet transcript of an investor call. “Everywhere you look there are variants and running a study at this time puts significant pressure on the vaccine.” The company’s late-stage study was conducted in part in South Africa, which is where the B.1.351 variant was first identified, and the vaccine was found to be about 64% efficacious there, which nearly all of the COVID-19 cases were found to be caused by that strain of the virus. Wall Street analysts largely caution against direct comparisons of the vaccines, in part due to differences in trial design and timeline, especially as new variants like B.1.1.7 and B.1.351 have gained traction in recent months, but they generally view J&J’s vaccine as a key ingredient in reducing the impact of the virus in the U.S. The J&J vaccine, which is referred to as Ad26.COV2.S, “is an effective single-dose vaccine with advantages in distribution that will likely contribute to substantially lowering the COVID-19 curve once available,” SVP Leerink analysts told investors on Feb. 24. “Though it remains premature to proclaim the beginning of the end for the pandemic, these data, along with EUA’s and availability for several vaccine candidates, signal to us that we are perhaps at ‘the end of the beginning.’” The topic of spreading variants in the U.S. was one that came up several times during an advisory committee meeting on Friday. The committee, which convened Friday as part of the traditional FDA regulatory process, voted 22-0 that the vaccine’s benefits outweigh the risks, therefore recommending that the FDA authorize the vaccine. About 22 million people in the U.S. have received both doses of either the BioNTech/Pfizer or Moderna vaccines since December, according to the Centers for Disease Control and Prevention. That’s about 7% of the total U.S. population. The U.S. has already agreed to purchase 100 million doses of J&J’s vaccine in the first half of this year, though the first batch of doses that will be delivered with only be around 20 million, by the end of March, a J&J executive told lawmakers on Feb. 23.

Below is a 3 mouth old interview. Most of the issues have been resolve. the mRNA vaccine is a modern miracle and a great scientific breakthrough

https://youtu.be/AM3gSgvN2Fw

https://youtu.be/YCHMnGGOBb0

House Democrats passed their sweeping $1.9 trillion coronavirus aid package in a party-line vote early Saturday morning, advancing President Biden’s top legislative priority. Lawmakers passed the bill 219-212, with two Democrats — Reps. Jared Golden (Maine) and Kurt Schrader (Ore.) — joining all Republicans in voting against it. Democrats could only afford up to four defections with their narrow House majority. The bill’s passage comes days after the COVID-19 death toll in the U.S. surpassed 500,000 people while more contagious virus variants remain a threat to containing the pandemic.

Lawmakers are hoping to build on the momentum from vaccines gradually reaching people to end the global pandemic that’s shaken up American life for most of the past year.

The relief package now heads to the Senate, where Democrats are expected to amend it next week and send it back to the House for approval before unemployment insurance benefits expire on March 14. The legislation, which was modeled after Biden’s proposal, includes provisions to provide a third round of direct stimulus checks of up to $1,400 for individuals, a $400 weekly unemployment insurance boost through Aug. 29, and $8.5 billion in funding for the Centers for Disease Control and Prevention (CDC) to distribute, track and promote public confidence in COVID-19 vaccines. The direct payments of up to $1,400 for individuals or $2,800 for married couples are the largest pandemic impact payments yet, after the two previous rounds last year maxed out at $1,200 and $600. Individuals with incomes of up to $75,000 and married couples earning up to $150,000 would be eligible for the full amounts, while the payments would phase out for individuals making up to $100,000 or $200,000 for couples. Other key parts of the massive package include $350 billion for state and local governments, $130 billion to help K-12 schools reopen for in-person classroom instruction, and an expansion of the child tax credit to $3,000 per child or $3,600 for children under six years of age. But one component of the bill that the House passed early Saturday is doomed to be left on the cutting room floor once it reaches the Senate: an increase in the federal minimum wage from the current $7.25 per hour to $15. The Senate parliamentarian ruled on Thursday that the minimum wage hike would not comply with the budget rules required to pass bills under the reconciliation process, which Democrats are using so that their pandemic relief package won’t be subject to a GOP filibuster in the upper chamber. House Democrats opted to keep the minimum wage provision in the bill as a show of support for the top progressive priority. “Even if it is inconceivable to some, it is inevitable to us. And we will work diligently to shorten the distance between the inevitable and the inconceivable,” Speaker Nancy Pelosi (D-Calif.) said of raising the wage. The push to raise the minimum wage to $15 has been met with strong pushback from Republicans and a handful of centrist Democratic lawmakers, who cited a Congressional Budget Office report estimating that while it would lift 900,000 people out of poverty, it would also lead to 1.4 million job losses. Only one sitting House Democrat, Rep. Kurt Schrader (Ore.), voted against a bill in 2019 to raise the minimum wage to $15. While Schrader’s preference for a regionally-adjusted minimum wage over a federal statute for $15 didn’t threaten the relief package’s prospects in the House, it’s a more delicate balance for Democrats’ 50-50 standing in the Senate. The final vote on the pandemic relief package didn’t occur until well after midnight on Saturday because Republicans delayed proceedings for several hours by speaking before the House Rules Committee on the more than 200 amendments they submitted to the bill. None of the GOP amendments, which ran the gamut from stripping the bill of the minimum wage provision to requiring K-12 schools to have reopening plans for in-person teaching in place in order to access full funding, were granted floor time. It’s possible that Democrats could pass a separate bill to increase the minimum wage, but it would be subject to a 60-vote threshold to clear a Senate GOP filibuster. “I guarantee you there’ll be a raise in the minimum wage before the election,” House Budget Committee Chairman John Yarmuth (D-Ky.) told reporters in the Capitol. “Hold me to it.” Progressives are calling for Vice President Harris, the president of the Senate, to overrule the parliamentarian’s advisory opinion or for Democrats to abolish the filibuster to ensure that the campaign promise of a minimum wage increase can eventually become law under Biden. “So it’s not just about minimum wage, because Democrats made a lot of promises in winning the House, the Senate and the White House. And it’s going to come up again and again. So we’re gonna have to make a choice here. Are we going to stick to these rules or are we actually going to use the levers of government to work for the people?” said Congressional Progressive Caucus Chairwoman Pramila Jayapal (D-Wash.).

(Bloomberg) — The House is poised to pass President Joe Biden’s $1.9 trillion Covid-19 stimulus, but a ruling by late Thursday by a Senate official dealt a major blow to prospects that the final legislation will include a hike in the U.S. minimum wage to $15 per hour.

Friday’s vote in the House will bring most Americans one step closer to receiving $1,400 relief payments and move action to the Senate, where disagreements among Democrats over the minimum wage had been the biggest obstacle to turning the pandemic relief plan into law.

However, Senate parliamentarian Elizabeth MacDonough found that the wage provision did not qualify for action under budget reconciliation, a fast-track procedure that would let Democrats pass the stimulus with only 50 votes in the evenly divided Senate. Democrats don’t yet have a unified approach for dealing with the minimum wage decision. While Biden called on Congress to “quickly” pass the relief bill, progressives are urging Democrats to overrule the parliamentarian or wage a battle over tax penalties to force higher wages. That raises the potential for disputes that delay Senate passage of the broader stimulus package. The $15 minimum wage had been a rallying point for progressive Democrats, and Senate Budget Chair Bernie Sanders immediately proposed a work-around to raise pay for low-level workers. “I will be working with my colleagues in the Senate to move forward with an amendment to take tax deductions away from large, profitable corporations that don’t pay workers at least $15 an hour and to provide small businesses with the incentives they need to raise wages,” Sanders said in a statement. “That amendment must be included in this reconciliation bill.” Senate Finance Chair Ron Wyden also endorsed the idea of a tax penalty for large corporation “that refuse to pay a living wage.”

Despite the 95 percent effectiveness at preventing coronavirus infection after two doses of its vaccine, Pfizer is now seeing what a third dose might do. The company announced Thursday that a booster dose is being studied among people who received their first doses of the vaccine more than six months ago. In an interview with NBC News’ Lester Holt, Pfizer CEO Albert Bourla said the hope is that a third dose will boost the immune response even higher, offering better protection against variants.

“We believe that the third dose,” Bourla said, “will raise the antibody response 10- to 20- fold.”

The new study will monitor the safety and efficacy of a third dose in two age groups: those 18 to 55 and those 65 to 85. The participants come from a group of people who were among the first to receive the Pfizer-BioNTech vaccine: people who volunteered for Pfizer’s initial Phase 1/2 clinical trial, which began in May. During that trial, participants received two doses of the vaccine three weeks apart. The same dose interval is what’s currently recommended. The third shot will be exactly the same as what participants got a year ago. Pfizer also plans to begin testing whether a modified version of the vaccine works well against the variant from South Africa. Indeed, as SARS-CoV-2 changes, the vaccines may have to be tweaked. The Food and Drug Administration issued guidance Monday saying vaccine manufacturers may be able to ease away from lengthy clinical trials to prove safety and effectiveness for vaccines that have been tweaked to account for variants. That’s not unlike how the flu shot changes from year to year, accounting for the strains most likely to infect people.

“Every year, you need to go to get your flu vaccine,” Bourla said. “It’s going to be the same with Covid. In a year, you will have to go and get your annual shot for Covid to be protected.”

That suggests that even when the pandemic ends, Covid-19 may be here to stay. Ongoing studies of re-engineered vaccines are necessary to understand when boosters may be needed, outside experts said. “You need to cast a wide net to find Goldilocks,” said John Grabenstein, a former executive director of medical affairs for vaccines at Merck and a former Defense Department immunologist. “You want to look at shorter intervals, you want to look at longer intervals, to determine when is the best time, if needed, to re-vaccinate.” So far, evidence suggests that the existing Pfizer-BioNTech vaccine remains effective against variants first identified in the U.K., Brazil and South Africa. Bourla said the company’s goal if and when another variant emerges is to pivot and tweak the current vaccine within 100 days. Moderna, which makes a similar Covid-19 vaccine, announced Wednesday that it had also started studying the effects of adding a third dose to its regimen and has developed a version of the vaccine designed to target the variant from South Africa.

A top Federal Reserve official on Friday pushed back on persistent worries that the economy’s recovery from the pandemic-recession this year could be derailed by excessive fiscal stimulus from Washington or a sudden reversal of ever-rising asset prices.

New York Fed President John Williams, a close ally of Chairman Jerome Powell, said he thinks the economy is still “in a very deep hole” and has a long way to go to get back to full strength.

In that light, Williams said “I am not really concerned about stimulus or fiscal support right now or anything like that. Really what I want to see is an economy that gets back to full strength as soon as possible.” He spoke in an interview with CNBC. Some economists think the $1.9 trillion Biden fiscal package is too large and could cause the economy to overheat. The yield on 10-year Treasurys has been steadily moving higher this month, and there is some concern it might slow the economy by raising borrowing costs. Williams said rising yields on longer term Treasurys reflects greater optimism about the economy “so it’s not a concern.” A separate report, released earlier Friday from the Federal Reserve, said “asset valuation pressures have returned to or exceeded pre-pandemic levels in most markets, including in equity, corporate bond, and residential real estate markets” Asked for comment, Williams said the rise in asset prices has been driven by optimism about the economy and expectation in financial markets that long-run interest rates will stay low. “The fundamentals kind of tell you that prices should be somewhat higher,” he said.

(Reuters) – Texas doctor Natasha Kathuria has practiced medicine in 11 countries, worked through the 2014 “Snowmageddon” storm that ground Atlanta to a halt, and survived the past year’s COVID-19 pandemic crush. But Kathuria and some other doctors in Texas are saying they have never seen a more harrowing week than this one. Record-setting cold weather has cut water and grid energy supplies to hospitals across a wide swath of Texas. Electricity and water services were resuming, but many homes and some hospitals still did not have either on Friday. Half the state’s population was under a “must-boil” order to ensure water is safe. “We’re overwhelmed, way more than we’ve been with COVID,” said Kathuria, who works in several Austin-area emergency rooms. “This system failure has completely rocked us in our ERs – and in our own homes.” Many hospital staffers have stayed in the medical facilities all week – knowing there was no heat or water at home. At least hospitals have generators for basic electricity. Some had water hauled in to fill tanks or hired water tankers. Others had running but not potable water. Doctors in Austin, Houston and the Dallas area called the lack of water their biggest problem. Dialysis machines do not work without water, surgery equipment cannot be sterilized, and hands cannot be washed. Dr. Neil Gandhi, an emergency room physician and the regional medical director for the ER departments at Houston Methodist’s seven hospitals in the area, said those facilities were at 90% operating capacity by Friday afternoon. Earlier in the week, two were able to take only emergency patients, Gandhi added. “On top of the COVID pandemic, this has been a dual trauma event for both our patients and our providers,” Gandhi said. Ambulances struggled to reach people on roads that were not cleared because Texas cities have few snow plows and not nearly enough salt on hand. Doctors in stand-alone emergency care locations who routinely call the 911 emergency number for ambulances to transfer patients to hospitals had to wait more than nine hours for any to arrive – if they were available at all. Gandhi said that in Houston this week there were times when entire neighborhoods simply did not have any emergency medical services. Hospitals set up portable toilets. Inside, patient’s toilets were flushed by tossing in a bucket of water. Less critical dialysis patients delayed treatment, while others limited their time on machines. Rural hospitals across Texas were not only trying to treat patients under tough conditions, but also serving as de facto “warming centers” for the healthy, said John Henderson, president of the Texas Organization of Rural and Community Hospitals. Even with warmer weather forecast for next week there could still be a sea of broken water pipes and other damage. “We worried that when the sun comes out and the temperature goes up,” Kathuria said, “that it’s not necessarily the end in sight.”