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‘Normalization’ Of Emergency Use Authorizations Concerns Health Experts

‘Normalization’ Of Emergency Use Authorizations Concerns Health Experts

Authored by Marina Zhang via The Epoch Times (emphasis ours),




'Normalization' Of Emergency Use Authorizations Concerns Health Experts

Authored by Marina Zhang via The Epoch Times (emphasis ours),

The Food and Drug Administration (FDA) has approved an unprecedented number of emergency use authorizations (EUAs) for drugs, tests, and medical devices since the beginning of the pandemic.

Medical syringes and FDA logo displayed in the background are seen in this illustration photo taken in Krakow, Poland on December 2, 2021. (Photo by Jakub Porzycki/NurPhoto via Getty Images)

Between March 2020 and June 2021, more than 600 EUAs were authorized, according to Fortune.

This has caused concern among healthcare professionals, with some studies claiming that overreaction by regulators may have led to a decline in industry standards (1, 2).

As clarified in the journal Yale Medicine, “An EUA can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh the potential risks. A EUA also only lasts as long as the public health emergency for which it was declared.”

Prior to 2020, the public health emergency that allowed the highest number of EUAs was the 2009 H1N1 pandemic, with 22 EUAs overall for personal protective equipment (PPE), antivirals, and diagnostic tests. The only emergency-authorized vaccine prior to the 2020 pandemic was the anthrax vaccine.

Given the drastic increase in EUAs, experts worry that this time, the FDA has gone too far.

The Normalization of EUA Drugs and Lack of Informed Consent

Cardiologist Dr. Jack Askins has pointed out that the unprecedented onslaught of emergency authorizations in drugs, vaccinations, medical devices, COVID tests, and PPE has normalized EUA drugs and products as being fully FDA-approved rather than being investigational.

Prof. Linda Wastila from the University of Maryland School of Pharmacy, whose expertise is in pharmacotherapy and drug policy, told The Epoch Times that the torrent of 600 EUAs makes it very difficult for healthcare professionals to remain informed of the approval statuses of new drugs.

For example, Askins previously told The Epoch Times that he noticed some of his colleagues who prescribe Paxlovid lacked adequate awareness of the many interactions and contraindications Paxlovid has with other drugs.

Paxlovid can interact with 43 different drug classes and over 550 active drug ingredients.

Even before the pandemic, it was hard for clinicians and pharmacists to keep up, given that around 40 novel therapeutics are approved by the FDA yearly, not counting generic drugs.

Wastila said that compared to traditional FDA-approved products, there has been less informed consent with the EUA products during the pandemic.

Informed consent is defined as “the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention,” and patients must make their own voluntary decision.

Informed consent is especially important with EUA products as they are investigational products. Articles on EUAs have compared taking these products to participating in experimental trials (1, 2).

Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, on Aug. 29, 2020. (Andrew Kelly/Reuters)

Part of informed consent is letting patients know that what they are taking is experimental and that they have the right to refuse.

But Askins highlighted that very few patients were provided informed consent when they took EUA products such as the vaccine.

He said that three patients, each of whom received the bivalent booster as a fourth shot, were admitted to his clinic. He asked all three if they were given information on the potential risks and the emerging data on concerns and problems with it.

“All three said no,” he said, “I do not think they understand emergency use authorization versus full FDA approval.

It also should be noted that EUAs do not come with long-term safety data.

While drugs fully approved by the FDA come with a densely written package insert on side effects and drug mechanisms, for many EUA products, such as the COVID-19 vaccines, these sections are left blank.

A Johnson & Johnson spokesperson said this was intentional, leaving it to consumers to search online for the most up-to-date information on safety and effectiveness as the data is published.

However, Wastila sees this lack of information as potentially dangerous.

“To me at least, [it] conveys the fact that they don’t really know whether a product is safe and effective when it’s an EUA product.”

The Erosion of Drug Safety Standards

Dr. David Bell, formerly a medical officer with the World Health Organization, said that the overuse of EUAs during the pandemic has lowered drug safety standards put in place to protect patients.

EUA products are very different from FDA-approved drugs. However, public health agencies’ encouragement to use EUAs has blurred the separation between EUAs and FDA-approved drugs.

Wastila fears that EUA is replacing FDA approval as the norm.

[EUAs] have lost all meaning,” said board-certified internist and nephrologist Dr. Richard Amerling. “People don’t hear ‘emergency use;’ they only hear ‘authorized.’”

Askins argued that there has been intentional public messaging from the FDA to make EUA appear just as safe and equivalent to a fully tested and licensed product.

In August 2021, the FDA approved the Pfizer COVID-19 vaccine under the label of Comirnaty.

Having an FDA-approved vaccine should have nullified the EUA for other COVID-19 vaccines, or at the very least, the Pfizer EUA vaccine.

Yet, the Pfizer EUA vaccine remains on the U.S. market. The FDA also wrote that for the Pfizer vaccine, “doses distributed under the EUA are interchangeable with the licensed doses.”

COVID-19 vaccine vials marked Comirnaty in Berlin, Germany, in a file image. (Tobias Schwarz/AFP via Getty Images)

An order issued in November 2021 by Judge Allen Windsor of the U.S. District Court for the Northern District of Florida rejected this claim, stating that while the two versions may be medically interchangeable, they are not legally interchangeable.

Judge Windsor’s order also mentioned that FDA officials could not prove that Comirnaty vaccines even exist in the United States.

Nevertheless, the full FDA approval of Comirnaty has led many health providers to assume that the Pfizer injections being administered are the licensed versions.

Wastila recounted an experience at her former local pharmacy.

She was picking up some antibiotics and, while chatting with the pharmacist, she asked about the uptake of Pfizer and Moderna vaccines.

“[The pharmacist] goes, ‘Oh, they’re great. Everyone’s so happy that they’re FDA approved,’” Wastila recounted. “That’s literally a quote from the pharmacist’s mouth.”

“I said, ‘They’re not FDA approved, though.’ She goes, ‘Oh, Pfizer is.’”

So Wastila asked to see an unopened package of the vaccine, and the pharmacist showed the doctor a vial.

The pharmacist presented an EUA vaccine; it did not have the Comirnaty label, which would be printed according to labeling requirements.

Wastila told the pharmacist that the pharmacy was still using the EUA vaccines.

“[The pharmacist] was just like kind of amazed,” said Wastila, “But there’s no informed consent if even your dispensers aren’t aware that it is EUA or FDA approved.”

More Emergency Declarations and EUAs Likely To Come

Health experts argue that COVID-19 pandemic management has already lowered the standards for future emergency declarations and EUAs.

Dr. Robert Malone, biochemist and one of the inventors of the mRNA drug platform, said that monkeypox, which was declared a public health emergency in August 2022 with no deaths in the U.S. at the time, is a good example of this reduced standard.

Given that the disease almost exclusively affects men who have sex with men, a specific population demographic, and has led to 20 deaths in the United States thus far, Bell and Wastila both said that it was ludicrous that it was deemed a public health emergency.

“Now the cat’s out the bag, [public health emergency declarations] can be used really easily now because there are precedents [such as] COVID-19 and monkeypox that were not very severe,” Bell said.

The smallpox vaccine, commercially labeled as JYNNEOS, was also rapidly given EUA approval in a matter of days.

The FDA wrote that it was “inferred” that a smallpox vaccine would be effective against monkeypox, given that both viruses are from the same family.

However, according to a statement made by the CDC on Oct. 19, 2022, there was no data on the effectiveness of JYNNEOS or ACAM2000, an alternative to JYNNEOS, for monkeypox.

A sign announcing monkeypox vaccination is set up in Tropical Park by Miami-Dade County and Nomi Health in Miami, Fla., on Aug. 15, 2022. (Joe Raedle/Getty Images)

The vaccine also has cardiological side effects. Pooled data across 22 studies showed that of the more than 7,800 people vaccinated, six developed cardiac-related adverse events that were determined to be causally related to vaccination.

Concerns have been raised about the respiratory syncytial virus, known as RSV, in children. Though the virus has not been declared a national public health emergency, declarations have been made in Oregon and Colorado, and some health experts have urged a national declaration.

“We’ve had RSV and the flu every year, and all of a sudden, it’s become a big issue again, and it’s because we’re afraid of every viral infection, [we’re] normalizing being fearful of every contagion,” said Wastila.

Loss of Trust in Public Health

As a pharmacotherapy professor who is in contact with pharmacists and staff working with the FDA, Wastila confessed that the pandemic has been a “rude awakening” for her.

“Physicians, dispensers, and pharmacists just blindly follow the safety and effectiveness of a product just because it has the FDA seal of approval, even if that ‘approval’ is an EUA.”

Though financial backdoor dealings have been suspected and discussed for decades, Malone argues that the pandemic has brought “corruption” to the surface.

Financially, 65 percent of the FDA’s budget comes from pharmaceutical companies, with a large proportion of this money coming through sponsorship for drug approval applications.

Comparing major drug regulators on conflicts of interest, according to data by Maryanne Demasi (The Epoch Times)

The 1992 Prescription Drug User Fee Act, also known as the PDUFA, requires pharmaceutical companies to pay the FDA for drug approvals.

Wastila said that after speaking to colleagues and students who work in the FDA, she senses that the PDFUA may have established “a culture of entitlement” from the drug companies to have their drugs approved and marketed.

“The sponsors feel like, hey, we’ve paid for this,” she said, “It’s like a pay-for-play situation.”

Many members of drug evaluation boards also receive financial payments from drug companies.

When evaluating a drug, there needs to be “zero conflict of interest,” said Amerling. “Declaring that you have a financial conflict of interest doesn’t make it go away.”

Bell said that the low uptake of vaccines in children under five years of age is a sign that people no longer trust public health agencies.

“They [The FDA] were unable to produce any solid data showing that there’s an all-cause benefit to those children,” said Bell.

For healthcare professionals and members of the public who once trusted the FDA, some feel that they no longer have a place to go for advice on treatments.

Amerling said this would force clinicians to be very conservative with their treatment.

As the Chief Academic Officer at The Wellness Company, Amerling educates doctors to prescribe only medications with a safety record of at least several years.

“Don’t be that person to jump on the bandwagon with a new product,” he said, “Post-marketing experience can reveal unanticipated adverse events, and you’re not going to see them even with the initial studies, even if they’re well done.”

“When medium and long-term risk is unknown, it’s best to err on the side of caution, especially if benefits are small.”

Wastila added that there has been a considerable information gap on drug safety since the pandemic, with little scrutiny from drug regulators.

Read more here...

Tyler Durden Fri, 01/13/2023 - 21:00

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New IRS Report Provides Fascinating Glimpse Into Your “Fair Share”

New IRS Report Provides Fascinating Glimpse Into Your "Fair Share"

Authored by Simon Black via,

Every year the IRS publishes…



New IRS Report Provides Fascinating Glimpse Into Your "Fair Share"

Authored by Simon Black via,

Every year the IRS publishes a detailed report on the taxes it collects. And the statistics are REALLY interesting.

A few weeks ago the agency released its most recent report. So this is the most objective, up-to-date information that exists about taxes in America.

This is important, because, these days, it’s common to hear progressive politicians and woke mobsters calling for higher income earners and wealthier Americans to pay their “fair share” of taxes.

But this report, directly from the US agency whose job it is to tax Americans, shows the truth:

The top 1% of US taxpayers paid 48% of total US income taxes.

And that’s just at the federal level, not even counting how much of the the local and state taxes the wealthy paid.

Further, the top 10% paid nearly 72% of total income taxes.

Meanwhile, the bottom 40% of US income tax filers paid no net income tax at all. And the next group, those making between $30-$50,000 per year, paid an effective rate of just 1.9%.

(Again, this is not some wild conspiracy theory; these numbers are directly from IRS data.)

But the fact that 10% of the taxpayers foot nearly three-fourths of the tax bill still isn’t enough for the progressive mob. They want even more.

The guy who shakes hands with thin air, for example, recently announced that he wants to introduce a new law that would create a minimum tax of 25% on the highest income earners.

But the government’s own statistics show that the highest income earners in America— those earning more than $10 million annually— paid an average tax rate of 25.5%. That’s higher than Mr. Biden’s 25% minimum.

So he is essentially proposing an unnecessary solution in search of a problem.

I bring this up because whenever you hear the leftist Bolsheviks in government and media talking about “fair share”, they always leave out what exactly the “fair share” is.

The top 1% already pay nearly half the taxes. Exactly how much more will be enough?

Should the top 1% pay 60% of all taxes? 80%? At what point will it be enough?

They never say. They’ll never commit to a number. They just keep expanding their thinking scope.

Elizabeth Warren, for example, quite famously stopped talking about the “top 1%” and started whining about the “top 5%”. And then the “top 10%”.

She has already decided that the top 5% of wealthy households should not be eligible for student loan forgiveness or Medicare.

And when she talks about “accountable capitalism” on her website, Warren calls out the top 10% for having too much wealth, compared to the rest of households.

Soon enough it will be the “top 25%” who are the real problem…

Honestly this whole way of thinking reminds me of Anthony “the Science” Fauci’s pandemic logic on lockdowns and mask mandates.

You probably remember how reporters always asked “the Science” when life could go back to normal… and he always replied that it was a function of vaccine uptake, i.e. whenever enough Americans were vaccinated.

But then he kept moving the goal posts. 50%. 60%. 70%. It was never enough. And there was never a concrete answer.

This same logic applies to what the “experts” believe is the “fair share” of taxes which the top whatever percent should pay.

They’ll never actually say what the fair share is. But my guess is that they won’t stop until 100% of taxes are paid by the top 10% … and the other 100% of taxes are paid by the other 90%.

Tyler Durden Wed, 03/29/2023 - 11:25

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Financial Stress Continues to Recede

Overview: Financial stress continues to recede. The Topix bank index is up for the second consecutive session and the Stoxx 600 bank index is recovering…



Overview: Financial stress continues to recede. The Topix bank index is up for the second consecutive session and the Stoxx 600 bank index is recovering for the third session. The AT1 ETF is trying to snap a four-day decline. The KBW US bank index rose for the third consecutive session yesterday. More broadly equity markets are rallying. The advance in the Asia Pacific was led by tech companies following Alibaba's re-organization announcement. The Hang Seng rose by over 2% and the index of mainland shares rose by 2.2%. Europe's Stoxx 600 is up nearly 1% and US index futures are up almost the same. Benchmark 10-year yields are mostly 1-3 bp softer in Europe and the US.

The dollar is mixed. The Swiss franc is leading the advancers (~+0.3%) while euro, sterling and the Canadian dollar are posting small gains. The Japanese yen is the weakest of the majors (~-0.6%). The antipodeans and Scandis are also softer. A larger than expected decline in Australia's monthly CPI underscores the likelihood that central bank joins the Bank of Canada in pausing monetary policy when it meets next week. Most emerging market currencies are also firmer today, and the JP Morgan Emerging Market Currency Index is higher for the third consecutive session. Gold is softer within yesterday's $1949-$1975 range. The unexpectedly large drop in US oil inventories (~6 mln barrels according to report of API's estimate, which if confirmed by the EIA later today would be the largest drawdown in four months) is helping May WTI extend its gains above $74 a barrel. Recall that it had fallen below $65 at the start of last week.

Asia Pacific

The US dollar is knocking on the upper end of its band against the Hong Kong dollar, raising the prospect of intervention by the Hong Kong Monetary Authority. It appears to be driven by the wide rate differential between Hong Kong and dollar rates (~3.20% vs. ~4.85%). Although the HKMA tracks the Fed's rate increases, the key is not official rates but bank rates, and the large banks have not fully passed the increase. Reports suggest some of the global banks operating locally have raised rates a fraction of what HKMA has delivered. The root of the problem is not a weakness but a strength. Hong Kong has seen an inflow of portfolio and speculative capital seeking opportunities to benefit from the mainland's re-opening.  Of course, from time-to-time some speculators short the Hong Kong dollar on ideas that the peg will break. It is an inexpensive wager. In fact, it is the carry trade. One is paid well to be long the US dollar. Pressure will remain until this consideration changes. Eventually, the one-country two-currencies will eventually end, but it does not mean it will today or tomorrow. As recently as last month, the HKMA demonstrated its commitment to the peg by intervening. Pressure on the peg has been experienced since last May and in this bout, the HKMA has spent around HKD280 defending it (~$35 bln).

The US and Japan struck a deal on critical minerals, but the key issue is whether it will be sufficient to satisfy the American congress that the executive agreement is sufficient to benefit from the tax- credits embodied in the Inflation Reduction Act. The Biden administration is negotiating a similar agreement with the EU. The problem is that some lawmakers, including Senator Manchin, have pushed back that it violates the legislature's intent on the restrictions of the tax credit. Manchin previously threatened legislation that would force the issue. The US Trade Representative Office can strike a deal for a specific sector without approval of Congress, but that specific sector deal (critical minerals) cannot then meet the threshold of a free-trade agreement to secure the tax incentives. 

The Japanese yen is the weakest of the major currencies today, dragged lower by the nearly 20 bp rise in US 10-year yields this week and the end of the fiscal year related flows. Some dollar buying may have been related to the expirations of a $615 mln option today at JPY131.75. The greenback tested the JPY130.40 support we identified yesterday and rebounded to briefly trade above JPY132.00 today, a five-day high.  However, the session high may be in place and support now is seen in the JPY131.30-50 band. Softer than expected Australian monthly CPI (6.8% vs. 7.4% in January and 7.2% median forecast in Bloomberg's survey) reinforced ideas that the central bank will pause its rate hike cycle next week. The Australian dollar settled near session highs above $0.6700 in North America yesterday and made a margin new high before being sold. It reached a low slightly ahead of $0.6660 in early European turnover. The immediate selling pressure looks exhausted and a bounce toward $0.6680-90 looks likely. On the downside, note that there are options for A$680 mln that expire today at $0.6650. In line with the developments in the Asia Pacific session today, the US dollar is firmer against the Chinese yuan. However, it held below the high seen on Monday (~CNY6.8935). The dollar's reference rate was set at CNY6.8771, a bit lower than the median projection in Bloomberg's forecast (~CNY6.8788). The sharp decline in the overnight repo to its lowest since early January reflect the liquidity provisions by the central bank into the quarter-end.


Reports suggest regulators are finding that one roughly 5 mln euro trade on Deutsche Bank's credit-default swaps last Friday, was the likely trigger of the debacle. The bank's market cap fell by1.6 bln euros and billions more off the bank share indices. Then there is the US Treasury market, where the measure of volatility (MOVE) has softened slightly from last week when it rose to the highest level since the Great Financial Crisis. While the wide intraday ranges of the US two-year note have been noted, less appreciated are the large swings in the German two-year yield. Before today, last session with less than a 10 bp range was March 8. In the dozen sessions since, the yield has an average daily range of around 27 bp. The rapid changes and opaque liquidity in some markets leading to dramatic moves challenges the price discovery process. The speed of movement seems to have accelerated, and reports that Silicon Valley Bank lost $40 bln of deposits in a single day.

Italy's Meloni government will tap into a 21 bln euro reserve in the budget to give a three-month extension of help to low-income families cope with higher energy bills but eliminate it for others. It is projected to cost almost 5 billion euros. The energy subsidies have cost about 90 mln euros. Most Italian families are likely to see higher energy bills, though gas will still have a lower VAT. Meloni also intends to adjust corporate taxes to better target them and cost less. Separately, the government is reportedly considering reducing or eliminating the VAT on basic food staples. Meanwhile, the EU is delaying a 19 bln euro distribution to Italy from the pandemic recovery fund. The aid is conditional on meeting certain goals. The EU is extending its assessment phase to review a progress on a couple projects, licensing of port activities, and district heating. These are tied to the disbursement for the end of last year. The EU acknowledged there has been "significant" progress. Italy has received about a third of the 192 bln euros earmarked for it. Despite the volatile swings in the yields, Italy's two-year premium over Germany is within a few basis points of the Q1 average (~46 bp). The same is true of the 10-year differential, which has averaged about 187 bp this year. 

After slipping lower in most of the Asia Pacific session, the euro caught a bid late that carried into the European session and lifted it to session highs near $1.0855. The session low was set slightly below $1.0820 and there are nearly 1.6 bln euros in option expirations today between two strikes ($1.0780 and $1.0800). Recall that on two separate occasions last week, the euro be repulsed from intraday moves above $1.09. A retest today seems unlikely, but the price actions suggest underlying demand. Sterling has also recovered from the slippage seen early in Asia that saw it test initial support near $1.2300. Yesterday, it took out last week's high by a few hundredths of a cent, did so again today rising to slightly above $1.2350. However, here too, the intraday momentum indicators look stretched, cautioning North American participants from looking for strong follow-through buying.


What remains striking is the divergence between the market and the Federal Reserve. On rates they are one way. Fed Chair Powell was unequivocal last week. A pause had been considered, but no one was talking about a rate cut this year. The market is pricing in a 4.72% average effective Fed funds rate in July. On the outlook for the economy this year, they are the other way. The median Fed forecast was for the economy to grow by 0.4% this year. The median forecast in Bloomberg's survey anticipated more than twice the growth and projects 1.0% growth this year. As of the end of last week, the Atlanta Fed sees the US expanding by 3.2% this quarter (it will be updated Friday). The median in Bloomberg's survey is half as much. 

The US goods deficit in February was a little more than expected and some of the imports appeared to have gone into wholesale inventories, which unexpectedly rose (0.2% vs. -0.1% median forecast in Bloomberg's survey). Retail inventories jumped 0.8%, well above the 0.2% expected and biggest increase since last August. Given the strength of February retail sales (0.5% for the measure that excludes autos, gasoline, food services and building materials, after a 2.3% rise in January), the increase in retail inventories was likely desired. FHFA houses prices unexpectedly rose in January (first time in three months, leaving them flat over the period). S&P CoreLogic Case-Shiller's measure continued to slump. It has not risen since last June. The Conference Board's measure of consumer confidence rose due to the expectations component. This contrasts with the University of Michigan's preliminary estimate that showed the first decline in four months. Moreover, when its final reading is announced at the end of the week, the risk seems to be on the downside, according to the Bloomberg survey. Meanwhile, surveys have shown that the service sector has been faring better than the manufacturing sector. However, the decline in the Richman Fed's business conditions, while its manufacturing survey improved, coupled with the sharp decline in the Dallas Fed's service activity index may be warning of weakness going into Q2.

The US dollar flirted with CAD1.38 at the end of last week is pushing through CAD1.36 today to reach its lowest level since before the banking stress was seen earlier this month. The five-day moving average has crossed below the 20-day moving average for the first time since mid-February. Canada's budget announced late yesterday boosts the deficit via new green initiatives and health spending, while raising taxes, including a new tax on dividend income for banks and insurance companies from Canadian companies. The market appears to be still digesting the implications. Today's range has thus far been too narrow to read much into it. The greenback has traded between roughly CAD1.3590 and CAD1.3615. On the other hand, the Mexican peso has continued to rebound from the risk-off drop that saw the US dollar surge above MXN19.23 (March 20). The dollar is weaker for fifth consecutive session and seventh of the last nine. It finished last week near MXN18.4450 and fell to about MXN18.1230 today, its lowest level since March 9. However, the intraday momentum indicators are stretched, and the greenback looks poised to recover back into the MXN18.20-25 area. Banxico meets tomorrow and is widely expected to hike its overnight target rate by a quarter-of-a-point to 11.25%.



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The ONS has published its final COVID infection survey – here’s why it’s been such a valuable resource

The ONS’ Coronavirus Infection Survey has ceased after three years. Two experts explain why it was a uniquely useful source of data.



March 24 marked the publication of the final bulletin of the Office for National Statistics’ (ONS) Coronavirus Infection Survey after nearly three years of tracking COVID infections in the UK. The first bulletin was published on May 14 2020 and we’ve seen new releases almost every week since.

The survey was based primarily on data from many thousands of people in randomly selected households across the UK who agreed to take regular COVID tests. The ONS used the results to estimate how many people were infected with the virus in any given week.

In the survey’s first six months, we had results from 1.2 million samples taken from 280,000 people. Although the number of people participating each month declined over time, the survey has continued to be a highly valuable tool as we navigate the pandemic.

In particular, because the ONS bulletins were based on surveying a large, random sample of all UK residents, it offered the least biased surveillance system of COVID infections in the UK. We are not aware of any similar study anywhere else in the world. And, while estimating the prevalence of infections was the survey’s main output, it gave us a lot of other useful information about the virus too.

Unbiased surveillance

An important advantage of the ONS survey was its ability to detect COVID infections among many people who had no symptoms, or were not yet displaying symptoms.

Certainly other data sets existed (and some continue to exist) to give a sense of how many people were testing positive. For example, earlier in the pandemic, case numbers were reported at daily national press conferences. Figures continue to be published on the Department of Health and Social Care website.

But these totals have usually only encompassed people who tested because they had reason to suspect they may have been infected (for example because of symptoms or their work). We know many people had such minor symptoms that they had no reason to suspect they had COVID. Further, people who took a home test may or may not have reported the result.

Similarly, case counts from hospital admissions or emergency room attendances only captured a very small percentage of positive cases, even if many of these same people had severe healthcare needs.

Symptom-tracking applications such as the ZOE app or online surveys have been useful but tend to over-represent people who are most technologically competent, engaged and symptom-aware.

Testing wastewater samples to track COVID spread in a community has proved difficult to reliably link to infection numbers.

Read more: The tide of the COVID pandemic is going out – but that doesn't mean big waves still can't catch us

What else the survey told us

Aside from swab samples to test for COVID infections, the ONS survey collected blood samples from some participants to measure antibodies. This was a very useful aspect of the infection survey, providing insights into immunity against the virus in the population and individuals.

Beginning in June 2021, the ONS survey also published reports on the “characteristics of people testing positive”. Arguably these analyses were even more valuable than the simple infection rate estimates.

For example, the ONS data gave practical insights into changing risk factors from November 21 2021 to May 7 2022. In November 2021, living in a house with someone under 16 was a risk factor for testing positive but by the end of that period it seemed to be protective. Travel abroad was not an important risk factor in December 2021 but by April 2022 it was a major risk. Wearing a mask in December 2021 was protective against testing positive but by April 2022 there was no significant association.

We shouldn’t find this changing picture of risk factors particularly surprising when concurrently we had different variants emerging (during that period most notably omicron) and evolving population resistance that came with vaccination programmes and waves of natural infection.

Also, in any pandemic the value of non-pharmaceutical interventions such wearing masks and social distancing declines as the infection becomes endemic. At that point the infection rate is driven more by the rate at which immunity is lost.

A woman wearing a face mask receives a vaccine.
The survey gave us insights into the protection offered by vaccines and non-pharmaceutical interventions. Paul Maguire/Shutterstock

The ONS characteristics analyses also offered evidence about the protective effects of vaccination and prior infection. The bulletin from May 25 2022 showed that vaccination provided protection against infection but probably for not much more than 90 days, whereas a prior infection generally conferred protection for longer.

After May 2022, the focused shifted to reinfections. The analyses confirmed that even in people who had already been infected, vaccination protects against reinfection, but again probably only for about 90 days.

It’s important to note the ONS survey only measured infections and not severe disease. We know from other work that vaccination is much better at protecting against severe disease and death than against infection.

Read more: How will the COVID pandemic end?

A hugely valuable resource

The main shortcoming of the ONS survey was that its reports were always published one to three weeks later than other data sets due to the time needed to collect and test the samples and then model the results.

That said, the value of this infection survey has been enormous. The ONS survey improved understanding and management of the epidemic in the UK on multiple levels. But it’s probably appropriate now to bring it to an end in the fourth year of the pandemic, especially as participation rates have been falling over the past year.

Our one disappointment is that so few of the important findings from the ONS survey have been published in peer-reviewed literature, and so the survey has had less of an impact internationally than it deserves.

Paul Hunter consults for the World Health Organization. He receives funding from National Institute for Health Research, the World Health Organization and the European Regional Development Fund.

Julii Brainard receives funding from the NIHR Health Protection and Research Unit in Emergency Preparedness.

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