British Medical Journal Demands Immediate Release of All COVID-19 Vaccine, Treatment Data

 by Katabella Roberts via The Epoch Times,

The British Medical Journal (BMJ) has demanded the full and immediate release of all data related to COVID-19 vaccines and treatments, saying it is in the public’s interest to do so.

BMJ, a weekly peer-reviewed medical trade journal published by the trade union the British Medical Association, called for the release of the data in an editorial published on Wednesday.

“Today, despite the global rollout of COVID-19 vaccines and treatments, the anonymized participant-level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come,” BMJ said.

“This is morally indefensible for all trials, but especially for those involving major public health interventions.”

BMJ also accused pharmaceutical companies of “reaping vast profits without adequate independent scrutiny of their scientific claims,” pointing to Pfizer, whose COVID vaccine trial was “funded by the company and designed, run, analyzed, and authored by Pfizer employees.”

New York-headquartered Pfizer still holds that trial data and has indicated that it won’t begin considering requests for such data until May 2025—24 months after the primary study completion date of May 15, 2023, which is listed on ClinicalTrials.gov.

Meanwhile, The Food and Drug Administration (FDA) had asked a judge to give it 75 years to produce all the data concerning the Pfizer and BioNTech vaccine.

However, a judge earlier this month ordered that the FDA make public 12,000 pages of the data it used to make decisions regarding approvals for the Pfizer/BioNTech COVID-19 vaccine by the end of the month. The FDA must also release Pfizer’s vaccine data at a rate of 55,000 pages a month until all of the requested pages are public.

BMJ also noted that AstraZeneca has indicated that it may be ready to entertain requests for data from a number of its phase III trials. However, the Cambridge-headquartered company says that the timeline for such data can “vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymization, and sharing of the requested data or documents.”

The Epoch Times has contacted spokespersons for Pfizer and AstraZeneca for comment.

“We are left with publications but no access to the underlying data on reasonable request,” BMJ said.

“This is worrying for trial participants, researchers, clinicians, journal editors, policymakers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymized individual participant data from clinical trials must be made available for independent scrutiny.”

BMJ added that regulators are not there to “dance to the tune of rich global corporations and enrich them further” but to protect the general public’s health and for that reason, they said, we need “complete data transparency for all studies, we need it in the public interest, and we need it now.”

In December, the Centers for Disease Control and Prevention (CDC) was also sued by the Informed Consent Action Network (ICAN) over claims that it is improperly withholding COVID-19 vaccine safety data from the American public.

ICAN is asking the CDC to provide de-identified post-licensure safety data for the COVID-19 vaccines in the CDC’s v-safe system so as to assure transparency with the general public regarding claims by both the CDC and the Biden administration that COVID-19 vaccines are “safe and effective.”

The British Medical Journal is one of the world’s oldest general medical journals, having been founded in 1840, and has editorial freedom from the British Medical Association.

https://www.zerohedge.com/covid-19/british-medical-journal-demands-immediate-release-all-covid-19-vaccine-treatment-data

Over 97,000 Americans Are Waiting For Kidney Transplants

 A genetically modified pig's heart has been successfully transplanted into a human for the first time.

The operation, performed in Baltimore in the United States on Friday, offers a potential future solution to long transplant waiting lists. Dr. Bartley Griffith, who performed the operation, described the situation on Monday:

“It creates the pulse, it creates the pressure, it is his heart,” adding: “It’s working and it looks normal. We are thrilled, but we don’t know what tomorrow will bring us. This has never been done before.”

In the infographic below, Statista's Katharina Buchholz takes a look at the size of the transplant waiting list problem in the U.S. According to the Health Resources & Services Administration, almost 120 thousand people were waiting for an organ in September 2021, with a kidney being the most needed (over 97 thousand) by far. A heart transplant was needed by around 3,500 people.

You will find more infographics at Statista

While the operation is being described as a watershed moment, Dr. David Klassen, the chief medical officer of the United Network for Organ Sharing, warns that there is still a long way to go before this is a valid option for a large number of patients:

“Doors are starting to open that will lead, I believe, to major changes in how we treat organ failure" but “Events like these can be dramatized in the press, and it’s important to maintain perspective. It takes a long time to mature a therapy like this.”

For now, the kidney is the organ most often transplanted in the U.S., and the number of transplants has more than doubled since the late 1980s. Kidneys, as well as livers, are donated by both deceased and living patients, which is why transplant numbers for these organs are higher than those for hearts and lungs.

You will find more infographics at Statista

In the case of kidneys, transplant numbers started rising more quickly in 2010 – a clear connection to the ongoing opioid crisis in the U.S. In a bittersweet twist of events, younger and healthier organ donors dying from overdoses increased the size of the donor pool significantly, since deceased donors can donate both, not just one, of their kidneys.

Similarly, one in six donor hearts in the U.S. is now coming from a person who died from an overdose.

https://www.zerohedge.com/medical/over-97000-americans-are-waiting-kidney-transplants

US To Close Borders To Unvaccinated Canadian, Mexican Truckers On Saturday

 By Nate Tabak of FreightWaves,

The U.S. will close its borders to unvaccinated and partially vaccinated Canadian and Mexican truck drivers on Saturday, the Department of Homeland Security said on Thursday.

“These updated travel requirements reflect the Biden-Harris Administration’s commitment to protecting public health while safely facilitating the cross-border trade and travel that is critical to our economy,” Secretary Alejandro Mayorkas said in a statement. 

The restrictions, which apply to all foreign essential workers, had been expected since U.S. officials announced them in October. They follow a similar rule that took effect at the Canadian border last Saturday.

The border COVID-19 vaccine mandates are coming into force despite pushback from the truck industry. The impact will be felt most acutely for the U.S.-Canada freight market, where around 160,000 truckers regularly cross the border — 75% of whom are Canadian.

Already capacity has tightened significantly, with huge price increases in the spot market. It adds to existing pressures, including COVID-19 itself, which left many fleets operating below full strength. 

“The supply chain is already fragile — so it puts all of us in a precarious situation,” Dan Einwechter, CEO of Canadian trucking and logistics firm Challenger Motor Freight, told FreightWaves.

The Canadian Trucking Alliance and American Trucking Alliance have projected that 10%-15% of drivers may leave cross-border trucking as a result of the mandates, and exacerbate existing supply chain issues. On Monday, several dozen Canadian truckers protested near the U.S. border in Emerson, Manitoba.

https://www.zerohedge.com/economics/us-close-borders-unvaccinated-canadian-mexican-truckers-saturday

Cruises sail on in Omicron wave as CDC rules go voluntary

 Cruise lines sailing in U.S waters can now decide if they want to follow COVID-19 guidance from the Centers for Disease Control and Prevention (CDC), which has frustrated would-be passengers and ship companies in the face of soaring Omicron variant cases.

After the CDC’s framework for Conditional Sailing order (CSO) — in place for cruise companies since 2020 — expired last week, the health agency’s guidance for cruise ships have become voluntary for ships operating in foreign and U.S. waters.

Previously, the CDC issued a warning to avoid cruising despite vaccination status, after the Omicron wave led to over 90 ships sailing with passengers from the U.S. under CDC investigations because of COVID-19 cases. But the CSO officially ended on January 15, and transitioned into a voluntary framework.

Non-participating vessels that sail internationally and operate within US waters will be classified as ‘gray’ on the CDC’s cruise ships color status website — indicating that the agency has not reviewed the health and safety protocols of the operators. Meanwhile, cruise ships that opt out and exclusively sail in US waters will not be listed on the website.

While the CDC made it clear that the new program is voluntary, it recommended cruise lines to follow its COVID-19 mitigation guidelines.

“There's a level of frustration because I think messaging throughout this whole pandemic has just been so tough, whether it be at the local, county or state level versus federal level and the CDC,” Alex Sharpe, President and CEO of Signature Travel Network, told Yahoo Finance in a phone interview.

It's unclear how many cruise ship operators are expected to opt in to the discretionary program. Norwegian Cruise Line Holdings (NCLH) has pledged to continue applying the protocols on a voluntary basis, as part of a "commitment to health and safety," the company said in a statement.

Separately, Tom McAlpin, President and CEO of Virgin Voyages, told Good Morning America in a recent interview that "of course we're going to opt in" to the voluntary protocols, noting that the recommendations “are working.”

The CDC’s move was also hailed by Cruise Lines International Association, an industry group. It said the transition to a voluntary program "recognizes the cruise industry’s unwavering commitment to providing some of the highest levels of COVID-19 mitigation found in any industry,” the group wrote.

'Very busy booking'

The Norwegian Pearl cruise ship is seen docked at Miami port, after Norwegian Cruise Line Holdings Ltd cancelled sailings amid rising fears of Omicron-related coronavirus infections, in Miami, Florida, U.S. January 5, 2022. Picture taken with a drone. REUTERS/Marco Bello

To be sure, the pandemic is still creating industry headaches, causing some cruise ships to cancel trips mid-voyage in the wake of coronavirus diagnoses. Meanwhile, Omicron has increased the number of positive cases among full vaccinated crew members. 

Recently, Norwegian Cruise Line's Gem ship was forced to cancel a 10-night trip to the Caribbean due to "COVID related circumstances." Nonetheless, industry experts say there's pent up demand from travelers. 

“We're very busy booking. I would say the second half of ‘22 and into ‘23 and cruise lines have some ‘24 itineraries out already,” Sharpe said. Yet the current environment has forced travel agents to provide clarifications on the updated protocols for cruise ships. 

“The whole thing kind of gets jammed up for this. And a lot of it is just clarify messaging,” Sharpe added. It's one reason why Wall Street remains bullish about how the industry's outlook as the CDC's order becomes voluntary.

“While we don’t think this changes anything about ship operations, we see it as a positive for sentiment on the cruise stocks,” Robin Farley, UBS analyst, wrote in a note to clients this month.

“The cruise lines have been already complying with CDC suggestions even in markets where they don’t have to, and we don’t expect that to change. We do think it will be a sentiment positive for the cruise stocks, further reducing the tail risk of any potential shutdown,” the firm added.

https://finance.yahoo.com/news/cruises-sail-on-as-cdc-rules-becomes-voluntary-travel-agents-clarify-messaging-170309762.html

FDA declines to OK Pfizer-Opko growth hormone deficiency treatment

 Pfizer Inc PFE.N said on Friday the U.S. health regulator has declined to approve the treatment for growth hormone deficiency in children that it developed with partner OPKO Health Inc OPK.O.

Pfizer's statement did not mention a reason for theU.S. Food and Drug Administration's (FDA) decisionin its complete response letter.

"We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric growth hormone deficiency patients and their families," said Brenda Cooperstone, chief development officer of Rare Disease, Pfizer Global Product Development.

Pfizer has submitted applications to regulators of various countries and Japan earlier this week approved the drug, which will be sold under the brand name Ngenla.

Growth hormone deficiency is a rare disorder where the pituitary gland does not produce enough growth hormone to stimulate the body to grow. It is characterized by abnormally short height and affects one in about 4,000 to 10,000 children globally.

https://www.nasdaq.com/articles/u.s.-fda-declines-to-approve-pfizers-growth-hormone-deficiency-treatment

NY expands absentee voting after defeat of ballot measure

 New Yorkers can again choose to vote by absentee rather than face the risk of catching COVID-19 at polling sites through the rest of 2022 under a bill that Gov. Kathy Hochul signed Friday.

The Assembly passed the bill 100-45 on Wednesday, and the Senate passed the bill last week with a 42-21 vote. One Democrat in the Senate and two Democrats in the Assembly opposed it.

Currently, New York law only allows an individual to request an absentee ballot if they will be absent from their county or New York City on Election Day, or if they have an illness, physical disability, or care-taking responsibilities for someone who is ill or disabled.

The new law again amends the definition of illness to include when a voter can’t go to a polling place because of the risk of contracting or spreading a harmful disease. New York first passed such legislation in 2020.

The Democratic governor has said she intends to allow every New Yorker to vote by absentee in 2022.

“Gov. Hochul is committed to restoring faith in government and elections, which is why she proposed a number of State of the State reforms to improve access to voting and safeguard elections in New York,” her spokesperson Hazel Crampton-Hays said.

The legislation’s passage comes months after voters in November defeated two proposed constitutional amendments that would have allowed same-day voting registration and permanent no-excuse absentee voting. Democrats wielding a legislative supermajority had expected both to easily pass.

“The failure of the voting rights ballot proposals in New York and the threat to voting rights across our nation place an even greater responsibility on the Legislature to do the right thing and prioritize voting reforms,” Sen. Alessandra Biaggi, a Democrat representing Bronx and Westchester, said.

One rejected amendment would have allowed for lawmakers to pass same-day voter registration by getting rid of a requirement that people register to vote at least 10 days before an election. The other failed amendment would have removed a constitutional restriction limiting absentee voting to New Yorkers who are ill, have a physical disability or are outside the country.

Democrats passed the constitutional amendments for two years in a row in the Legislature: a requirement for getting referendum on the ballot.

But the state’s Conservative Party waged a successful, multi-million campaign against the referendum in the final days leading up to the November election. State campaign finance reports show the party spent nearly $4.2 million on radio and online ads beginning in mid-October.

The Conservative Party’s ads argued that same day voter registration and expanded absentee voting would weaken election security.

Democrats did not mount a statewide campaign in support of the referendum — a decision blasted by voting right supporters who have long pushed for the reforms.

New York still took some steps to make voting easier last year: Hochul signed bills in December to increase the mandated number of early voting sites and require absentee ballots to be counted in time for unofficial results to be known on election night.

Since New York rolled out early voting in recent years, voting rights activists have criticized the lack of polling places and limited hours.

And in 2020, the presidential election was marked by delays as counties tallied up a tsunami of absentee ballots.

Republican state election commissioners Peter Kosinski and Anthony Casale slammed Hochul and lawmakers for passing the two laws: “These actions are a direct threat to the integrity of the election process, designed to make it easier to manipulate the votes of people voting by absentee ballot.”

A December review by The Associated Press found fewer than 475 potential cases of voter fraud in the six battleground states disputed by former President Donald Trump — a number that would have made no difference in the 2020 presidential election.

Leaders of the state Senate say the Democratic majority will pass a pile of other election bills this year: ranging from allowing portable polling sites to make early voting easier in rural areas, to allowing local election boards to set up drop boxes for absentee ballots.

Currently, New York only accepts voting registration applications that are postmarked 25 days before an election and received 20 days before a primary or general election.

Another bill supported by Senate Democrats would allow voters to register sooner: boards of election could accept applications received 10 days before a primary or general election.

The fate of other election bills is unclear.

Sen. Brad Hoylman is again proposing to prohibit the use of campaign funds to pay a candidate’s attorney’s fees or other costs from criminal or civil litigation. He’s argued that it’s unfair for donors to fund legal bills.

Hoylman’s bill was referred to the Senate elections committee in early January.

It’s failed to pass for years, with critics pointing to the higher threat of legal action facing lawmakers.

Former Gov. Andrew Cuomo has reported paying $1.7 million in legal fees over the past year. That includes nearly $900,000 for his attorney Rita Glavin, who has represented Cuomo in criminal and civil probes.

Cuomo also paid $800,000 to Sullivan & Cromwell, whose attorney Sharon Nelles helped represent Cuomo for the sexual harassment probe launched by the state attorney general’s office.

Cuomo could ask the state to reimburse his campaign for those fees following an Albany judge’s decision to dismiss the sole criminal charge against Cuomo stemming from sexual harassment allegations.

Cuomo’s spokesperson Rich Azzopardi said he does not know whether Cuomo will do so.

https://apnews.com/article/voting-rights-new-york-albany-legislature-kathy-hochul-c7ac5a99190f012f35e88bcd5e980fd0

NFL ends daily COVID-19 testing for all players

 The NFL is curtailing daily testing of all players, vaccinated or unvaccinated, for COVID-19.

In a memo sent to the 32 clubs and obtained by The Associated Press, the league said Friday that medical experts from the NFL and the players’ union agreed to the change. Those doctors have seen enough evidence of a decrease in positive tests in the last month to feel comfortable with dropping daily tests.

Last month, weekly testing for vaccinated players and personnel was stopped, but anyone who reported symptoms of COVID-19 or was part of targeted surveillance still was subjected to testing.

“Following consultation with our jointly retained infectious disease experts, the NFL and NFL Players Association have updated the NFL-NFLPA COVID-19 protocols to eliminate the distinction between vaccinated and unvaccinated players to determine testing cadence,” the memo said. “Effective immediately, all players and tiered staff will be subject to strategic and targeted testing.”

The league will continue symptom-based testing and screening for symptoms.

“This comprehensive, symptom-based approach to testing reflects our recent experience with the omicron variant and conforms to current public health recommendations and best practices employed in healthcare,” the memo said, “and offers the best opportunity for identifying and treating cases promptly and avoiding spread within the facility.”

https://apnews.com/article/coronavirus-pandemic-nfl-sports-health-business-25b75fccf98e06df79b748675d82bc1a