NBC;

Pfizer-BioNTech is postponing its rolling application to the Food and Drug Administration to expand the use of its two-dose Covid-19 vaccine for children ages 6 months to 4 years.

The move means that vaccines for this age group will not be available in the coming weeks, a setback for parents eager to vaccinate their young children.

More: FDA and Pfizer postpone review of #covid19 vaccine for kids under 5 to await three-dose data (back to the drawing board), noting additional findings from ongoing clinical trial.
 
Via Edward Dowd (former Blackrock Exec): $PFE This is what we call a huge tell in the investment world. They know the truth is coming…long only folks should run not walk to the exits.

Update.

Coronavirus booster shots lose much of their potency after about four months, raising the possibility that some people may need a fourth dose, new CDC data suggest. https://t.co/UihLT8iiUz

— The New York Times (@nytimes) February 11, 2022

So, this is what the new normal looks like.

Also, while rare — learn the signs of energy bill side effects.

Disappeared.

It appears the Board of Health has made the video private. Luckily somebody sent me a clip yesterday. Here it is for your viewing pic.twitter.com/GHjmZrnuOE

— Liberal Parent (@Liberal_Parent) January 21, 2022

The British Medical Journal, Editorial

In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.

The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data. Public battles for drug company data, transparency campaigns with thousands of signatures, strengthened journal data sharing requirements, explicit commitments from companies to share data, new data access website portals, and landmark transparency policies from medicines regulators all promised a new era in data transparency.

Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised 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.This is morally indefensible for all trials, but especially for those involving major public health interventions.

Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data. And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).

The lack of access to data is consistent across vaccine manufacturers. Moderna says data “may be available … with publication of the final study results in 2022.” Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427).

As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials. But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”

Underlying data for covid-19 therapeutics are similarly hard to find.

Read it all.

Tangentially related: Saskatchewan’s new cases by vaccination status numbers are back up at SaskHealth. I’m told the problems with cleaning up this database aren’t completely resolved, but the latest information should be accurate.

January 20th: “Of the 1,158 new cases reported today, 221 were unvaccinated or fewer than 21 days after their first dose, 57 had received their first dose or were less than 21 days from their second dose, 637 were fully vaccinated (more than 14 days since their second dose) and 243 were fully vaccinated and more than 14 days from receiving their booster dose”.

Well, that’s more like it. And as suspected, the trends defy the narrative that vaccine passports are necessary to slow transmission of the virus. This outrageous policy of scapegoating citizens, many of whom have naturally acquired immunity, must go and soon, because the passport policy picks winners and losers. Locally owned restaurants, bars and gyms are once again paying the price while big box chains like Costco carry on business as usual. And for no measurable benefit. That’s simply unsustainable.