Observational studies of COVID vaccine efficacy are riddled with bias/ Not counting cases 14 days after dose 2 is a problem

Link:https://www.drvinayprasad.com/p/observational-studies-of-covid-vaccine

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In the experiment, he says, what if we compare the control arm of the Pfizer study against an imaginary vaccine arm. And for the thought experiment assume the vaccine is useless. As the table above shows, both groups have identical numbers of covid cases— just what you would expect from a useless vaccine. A straight forward analysis shows no benefit (second to last row)

But in the ‘fictional vaccine observational study’ cases are excluded for 36 days. When this is done the useless vaccine, looks like it reduces infections by 48%!!

Doshi makes a very good point in his paper that the solution is to subtract the 36 day infection rate from the observational control arm. Sadly most investigations don’t do that.

This is one of several biases Doshi discusses, and it plagues the vaccine literature.

Author(s): Vinay Prasad

Publication Date: 14 May 2024

Publication Site: Vinay Prasad’s Observations and Thoughts, substack

Essential Terms of the Authority Crisis

Link: https://polimath.substack.com/p/essential-terms-of-the-authority

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This last week, the CDC held their ACIP meeting to discuss whether or not they should recommend the COVID vaccines for children 6 months to 5 years old. While presenting on the danger of the virus for children, a slide was shown claiming that COVID presented as one of the leading causes of death for children.

Kelley, who runs covid-georgia.com, saw this slide and immediately knew it was false. She has been tracking COVID data in excruciating detail in Georgia since the beginning of the pandemic and has recently become an expert on the CDC’s pediatric death data simply because it was such a disaster and she wanted to get down to the truth of the matter.

This slide above is no small error. Not only did it count the wrong number for pediatric COVID deaths, it compared all pediatric COVID deaths in a 26-month period to annualized deaths from other causes. This is a massive data error, and yet it persisted through a supposedly rigorous data check from 11 authors and was selected by top-tier scientists for their landmark presentation to the most knowledgeable experts in the field.

Author(s): Matt Shapiro

Publication Date: 21 Jun 2022

Publication Site: Marginally Compelling at substack

J&J and Delta update

Link: https://yourlocalepidemiologist.substack.com/p/j-and-j-and-delta-update

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Neutralizing antibodies in a lab is difficult to map to real world efficacy. Thankfully, some scientists figured out a mathematical model (here). Using their model, this means the efficacy of J&J would be around 55-60% against symptomatic disease. It will still work well against severe disease.

In the same update, J&J said their vaccine continues to work over time, with strong responses for up to 8 months. This is because there’s only 8 months of data; we are optimistic it will last longer.

Author(s): Katelyn Jetelina

Publication Date: 2 July 2021

Publication Site: Your Local Epidemiologist on substack

India’s Covid crisis hits Covax vaccine-sharing scheme

Link: https://www.bbc.com/news/world-57135368

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Unicef is calling on the G7 countries – Canada, France, Germany, Italy, Japan, the UK and the US, as well as the EU, to donate their surplus supplies urgently.

Some countries have ordered enough to vaccinate their population many times over, including the UK, US and Canada.

In February British Prime Minister Boris Johnson promised to donate most of the UK’s surplus supply to poorer countries but he has so far given no specific timescale. It is a similar story for the US. So far France is the only G7 country to donate doses in view of the crisis in India.

Author(s): Tulip Mazumdar

Publication Date: 16 May 2021

Publication Site: BBC News

Covid-19 Vaccinations Are Slowing, So Officials Target Markets, Schools

Link: https://www.wsj.com/articles/covid-19-vaccinations-are-slowing-so-officials-target-markets-schools-11620044791

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As demand wanes, states, municipalities and healthcare providers are trying everything from one-on-one education in nontraditional locations to incentives including a free drink and cash.

West Virginia Gov. Jim Justice said recently the state would offer a $100 savings bond to residents aged 16 to 35 who receive a vaccination. The state had been an early leader in vaccinations.

In Detroit, $50 prepaid debit cards are being offered to drivers who take a city resident for a shot. In Connecticut, Gov. Ned Lamont rolled out a campaign where some restaurants will give a free drink to anyone who shows a vaccination card.

Author(s): Melanie Grayce West, Talal Ansari

Publication Date: 3 May 2021

Publication Site: Wall Street Journal

U.S. Lifts Pause, Will Restart J&J Vaccinations with Warning

Link: https://www.nationalreview.com/news/u-s-should-restart-jj-vaccinations-with-warning-cdc-advisory-group-says/

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The United States will resume Johnson & Johnson COVID-19 vaccinations after health officials lifted an 11-day pause on the shots at the recommendation of a Centers for Disease Control and Prevention advisory panel on Friday.

The pause in inoculations was triggered by concerns over six cases of a rare blood clot that occurred out of more than 7 million people who had received the vaccine in the U.S.

The panel voted 10 to 4 to recommend restarting the vaccinations, saying the benefits of the shot outweigh the rare risk of blood clots. However, the group suggested that the vaccine include a warning about the increased risk of the very rare but severe blood clots.

Author(s): Brittany Bernstein

Publication Date: 23 April 2021

Publication Site: National Review

Pfizer Identifies Fake Covid-19 Shots Abroad as Criminals Exploit Vaccine Demand

Link: https://www.wsj.com/articles/pfizer-identifies-fake-covid-19-shots-abroad-as-criminals-exploit-vaccine-demand-11619006403

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Fake shots for the pandemic can be easy to distinguish from real ones, experts said, because legitimate ones can be found for now sold only to governments, making any shots for sale on the internet counterfeit and potentially harmful.

Police in China and South Africa last month seized thousands of doses of counterfeit Covid-19 vaccines in warehouses and manufacturing plants, arresting dozens of people, according to the international police agency Interpol. Mexico also is investigating a shipment of some 6,000 doses of purported Sputnik vaccine from Russia, which were seized from a private plane headed to Honduras in March.

The Russia Direct Investment Fund, which leads efforts to market the vaccine internationally, said an analysis of photographs of the seized batch “suggests that it is a fake.” The Mexican Attorney General’s Office said it was investigating the matter and declined to comment further. Authorities haven’t determined whether the vaccines are genuine.

For months, agents from the National Intellectual Property Rights Coordination Center, an investigative arm of the U.S. Department of Homeland Security, have been investigating fraud related to the Covid-19 pandemic globally, recovering $48 million of phony masks, personal protective equipment and other products. Last fall, investigators shifted their focus to include Covid-19 vaccines that were nearing potential clearance by regulators, beginning with online scams. They have removed 30 websites and seized 74 web domains, according to IPR Center officials.

Author(s): Jared S. Hopkins, José de Córdoba

Publication Date: 21 April 2021

Publication Site: Wall Street Journal

First Dose of Chinese Covid-19 Vaccine Offers Little Protection, Chile Learns

Link: https://www.wsj.com/articles/first-dose-of-chinese-covid-19-vaccine-offers-little-protection-chile-learns-11618775502

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Across Chile — which has mounted one of the world’s most rapid vaccination campaigns using the vaccine made by Chinese drugmaker Sinovac Biotech Ltd. — health authorities are scrambling to deal with a surge in new infections and deaths.

More than 7.6 million people, half of Chile’s adult population, have received at least one vaccine dose, most made by the Chinese drugmaker, making the country a testing ground for a vaccine Beijing is supplying to countries across the developing world.

The problem, public-health officials say, was that people in general overestimated the effectiveness of the vaccine after only one of the two recommended doses and moved to ease up on pandemic-control restrictions too soon.

“With one dose, we know the protection is very weak,” said Claudia Cortes, an infectious-disease expert at the Santa Maria Clinic in Santiago, where about 10% of the Covid-19 patients at her hospital have received one shot. “It was not clearly explained that you need two doses — that you need to wait.”

Author(s): Ryan Dube

Publication Date: 18 April 2021

Publication Site: Wall Street Journal

In clinical and real world trials, China’s Sinovac underperforms

Link: https://www.economist.com/graphic-detail/2021/04/15/in-clinical-and-real-world-trials-chinas-sinovac-underperforms

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THE LATEST results for China’s CoronaVac vaccine, developed by Sinovac Biotech, a Beijing-based pharmaceutical company, were disappointing for the aspiring scientific and technological powerhouse. Phase-three trials, which were conducted on health-care workers in Brazil, yielded an efficacy rate of just 50.7% (with a 95% confidence interval of 35.7% to 62.2%), just barely above the 50% threshold set by the World Health Organisation for covid-19 vaccines (see chart). The results of a real-world trial released a week earlier were even worse: the vaccine was estimated to be just 49.6% effective (11.3% to 71.4%) against symptomatic covid-19 cases; when asymptomatic infections were included, this figure dropped to a dismal 35.1%.

The Chinese authorities’ reaction did little to boost confidence. After news broke of the discouraging results, Gao Fu, head of the Chinese Centre for Disease Control and Prevention, admitted at a conference on April 10th that current vaccines “don’t have very high rates of protection”, and suggested that vaccines could be mixed to improve efficacy. Mr Gao later backtracked from the comments, claiming that it was “a complete misunderstanding”.

Publication Date: 15 April 2021

Publication Site: The Economist

Massachusetts COVID-19 Vaccine Tracker

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COVID-19 vaccination, particularly the disparity of rates between racial and ethnic groups, takes up much of the current talk about the pandemic. The Massachusetts Department of Public Health (DPH) publishes vaccination data every day, for municipalities, tracking rates by age group, racial and ethnic groups, and by gender.

Pioneer is proud to present a new vaccine tracker, the newest tool in our COVID-19 tracking project. Pioneer distilled the vaccination data down to those who are either fully vaccinated or partially vaccinated, by all the demographic categories published by the DPH. Use the new tool below to compare rates among groups, by municipality and by county. We will update the data every week.

Date Accessed: 20 April 2021

Publication Site: Pioneer Institute

What Makes You More Likely to Get Side Effects From COVID Vaccine?

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Chicago’s top doctor, Chicago Department of Public Health Commissioner Dr. Allison Arwady, broke it down Thursday, saying in Facebook Live that younger people are more likely to experience side effects “because younger people have more robust immune system broadly.”

And, according to Loafman, the body’s immune system is what creates the symptoms.

“That’s simply a reflection of the immune response, just the way we have when we get ill,” he said.

Publication Date: 13 April 2021

Publication Site: NBC Chicago

J&J Covid-19 Vaccine Pause Driven by Risk of Mistreating Blood Clots

Link: https://www.wsj.com/articles/j-j-covid-19-vaccine-was-paused-over-blood-clot-treatment-concerns-11618777554

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U.S. health authorities came close to simply warning about a blood-clotting risk from Johnson & Johnson’s Covid-19 vaccine, but they decided to recommend pausing use out of concern doctors would improperly treat the condition, people familiar with the matter said.

Over the previous four weeks, U.S. health officials had become alarmed about similar blood-clotting conditions in Europe involving a Covid-19 vaccine from AstraZeneca PLC, the people said. The officials dug into a U.S. vaccine safety database and identified the cases of great concern, but they debated what action to take.

By the night of April 12, the officials resolved that urgent action was needed, the people said. Four of six women in the U.S. who developed the clots days after vaccination had initially been given blood thinner heparin, according to the federal Centers for Disease Control and Prevention. Its use could have worsened the patients’ condition, the people said.

Author(s): Thomas M. Burton and Betsy McKay

Publication Date: 18 April 2021

Publication Site: Wall Street Journal