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New countries stockpile antiviral TPOXX as monkeypox outbreak continues

pharmaphorum editor in chief Jonah Comstock talks to Philip Gomez, CEO of Siga Technologies, about how his company’s
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pharmaphorum editor in chief Jonah Comstock talks to Philip Gomez, CEO of Siga Technologies, about how his company’s antiviral drug can play a crucial role in addressing monkeypox cases.

Although the World Health Organization is still rating the current monkeypox outbreak as a moderate threat, the disease has continued to spread, with 2,103 cases in 42 countries and one confirmed death, according to the latest WHO data.

Accordingly, countries around the world are gearing up to address the outbreak. Yesterday, SIGA Technologies, makers of the antiviral drug TPOXX (tecovirimat), announced that it has received $13 million in procurement orders for the drug, including two new international jurisdictions and an approximate $2 million order from a country with an established contract with the company.

“Before the monkeypox outbreak, really, only the US and Canada had stockpiled our drug and very few people had actually stockpiled the vaccine between Canada, the US, and a few other countries,” Siga CEO Phil Gomez told pharmaphorum. “So not a lot of people were prepared for this, even though there’s been a lot of discussions over the years that this family of viruses is very deadly and everyone should have product.”

TPOXX is approved in Europe for the treatment of monkeypox and in the US and elsewhere for the treatment of smallpox, but can be prescribed off-label. One of the new countries stockpiling the drug is in Europe. The other, and the existing customer, are in the Asia-Pacific region, according to the company.

The orthopox threat

Monkeypox is a part of the orthopox family of viruses, which also includes smallpox, a deadly and contagious disease that was irradicated in the 1980s in an unprecedented immunisation campaign. Monkeypox is both less contagious and less deadly than smallpox, with the West African clade (the version of the virus involved in the current outbreak) having an estimated 1% fatality rate in humans.

The vaccines used to irradicate smallpox also offer some protection from other orthopox viruses, which might be one reason that the virus has rarely spread outside of Africa before this outbreak. But smallpox vaccination was halted in 1980, so the portion of the population with that crossover immunity is dwindling.

“I was at the US National Institutes of Health, at the National Institute of Allergy and Infectious Disease, a place called the Vaccine Research Center,” Gomez said. “I was part of the team that worked on the first SARS vaccine that went into humans. And I think what we’ve learned post-COVID … is we should think about families of viruses and the threats they may pose. So when I worked on that SARS vaccine, we probably should have developed a pan-coronavirus vaccine rather than SARS or MERS. Because then we had COVID-19. And the orthopox family viruses is one of those families that we’ve been worried about for a long time, because smallpox is in that family.”

In the case of monkeypox, it is still not clear what factors are behind this outbreak.

“If you talk to public health experts, they’ve always been worried about this because either the virus started to transmit person to person because we happened to hit a population that had close contact, or the virus evolved and became more transmissible. And so I think in this outbreak, people are leaning towards the former. But to be honest, we got to wait for the data to come out and understand why it does seem to be behaving differently,” Gomez said.

Vaccines and antivirals

One thing that makes monkeypox very different from COVID-19 is that it appears to have a much longer asymptomatic incubation period. This means that even though there is a vaccine for monkeypox, and several smallpox vaccines effective against monkeypox, it’s a challenge to stay ahead of the infection chains with vaccination.

“Monkeypox is about one to two weeks where the person doesn’t know that they’ve been infected,” Gomez said. “Obviously, the vaccine is effective if given prior to infection or even within the first days of infection. But once they progress and show up with symptoms, really the only thing that will mitigate the impact is an antiviral drug.”

TPOXX not only helps with symptoms and survivability, it also reduces patients’ viral load, making them less likely to infect others.

“So, one of the discussions is, as part of this outbreak, should we be giving an antiviral drug to people who may have been exposed?” Gomez said. “And we actually have been examining that for a number of years through the support of an R&D grant from the US military, where we actually give drug and vaccine to people at the same time. The vaccine would protect them long term and the drug would immediately both protect them and if they had it, and potentially reduce their infectivity.”

As evidenced by yesterday’s news, countries are stockpiling both vaccines and TPOXX, and attempting to contain the outbreak through contact tracing and ring vaccination.

“Many people, and I think even the US government’s initial reaction was vaccines, vaccines, vaccines,” Gomez said. “And I’ve worked in vaccines my whole career, so I totally believe in that. In this outbreak, though, it really is going to be the interplay of antiviral drugs and vaccines that potentially are the toolset that helps us stop some of this transmission, make sure that people don’t have severe disease, and hopefully reduce the outbreak.”

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Coronavirus dashboard for October 5: an autumn lull as COVID-19 evolves towards seasonal endemicity

  – by New Deal democratBack in August I highlighted some epidemiological work by Trevor Bedford about what endemic COVID is likely to look like, based…

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 - by New Deal democrat

Back in August I highlighted some epidemiological work by Trevor Bedford about what endemic COVID is likely to look like, based on the rate of mutations and the period of time that previous infection makes a recovered person resistant to re-infection. Here’s his graph:




He indicated that it “illustrate[s] a scenario where we end up in a regime of year-round variant-driven circulation with more circulation in the winter than summer, but not flu-like winter seasons and summer troughs.”

In other words, we could expect higher caseloads during regular seasonal waves, but unlike influenza, the virus would never entirely recede into the background during the “off” seasons.

That is what we are seeing so far this autumn.

Confirmed cases have continued to decline, presently just under 45,000/day, a little under 1/3rd of their recent summer peak in mid-June. Deaths have been hovering between 400 and 450/day, about in the middle of their 350-550 range since the beginning of this past spring:



The longer-term graph of each since the beginning of the pandemic shows that, at their present level cases are at their lowest point since summer 2020, with the exception of a brief period during September 2020, the May-July lull in 2021, and the springtime lull this year. Deaths since spring remain lower than at any point except the May-July lull of 2021:



Because so many cases are asymptomatic, or people confirm their cases via home testing but do not get confirmation by “official” tests, we know that the confirmed cases indicated above are lower than the “real” number. For that, here is the long-term look from Biobot, which measures COVID concentrations in wastewater:



The likelihood is that there are about 200,000 “actual” new cases each day at present. But even so, this level is below any time since Delta first hit in summer 2021, with the exception of last autumn and this spring’s lulls.

Hospitalizations show a similar pattern. They are currently down 50% since their summer peak, at about 25,000/day:



This is also below any point in the pandemic except for briefly during September 2020, the May-July 2021 low, and this past spring’s lull.

The CDC’s most recent update of variants shows that BA.5 is still dominant, causing about 81% of cases, while more recent offshoots of BA.2, BA.4, and BA.5 are causing the rest. BA’s share is down from 89% in late August:



But this does not mean that the other variants are surging, because cases have declined from roughly 90,000 to 45,000 during that time. Here’s how the math works out:

89% of 90k=80k (remaining variants cause 10k cases)
81% of 45k=36k (remaining variants cause 9k cases)

The batch of new variants have been dubbed the “Pentagon” by epidmiologist JP Weiland, and have caused a sharp increase in cases in several countries in Europe and elsewhere. Here’s what she thinks that means for the US:


But even she is not sure that any wave generated by the new variants will exceed summer’s BA.5 peak, let alone approach last winter’s horrible wave:



In summary, we have having an autumn lull as predicted by the seasonal model. There will probably be a winter wave, but the size of that wave is completely unknown, primarily due to the fact that probably 90%+ of the population has been vaccinated and/or previously infected, giving rise to at least some level of resistance - a disease on its way to seasonal endemicity.

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JOLTs jolted: Did the Fed break the labour market?

In the Bureau of Labor Statistics (BLS) August release of the Job Openings and Labor Turnover Survey (JOLTS) report, the number of job openings, a measure…

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In the Bureau of Labor Statistics (BLS) August release of the Job Openings and Labor Turnover Survey (JOLTS) report, the number of job openings, a measure of demand for labour, fell to 10.1 million. This was short of market estimates of 11 million and lower than last month’s level of 11.2 million.

It also marked the fifth consecutive month of decreases in job openings this year, while the August unemployment rate had ticked higher to 3.7%, near a five-decade low.

In the latest numbers, the total job openings were the lowest reported since June 2021, while incredibly, the decline in vacancies of 1.1 million was the sharpest in two decades save for the extraordinary circumstances in April 2020. 

Healthcare services, other services and retail saw the deepest declines in job openings of 236,000, 183,000, and 143,000, respectively.

With total jobs in some of these sectors settling below pre-pandemic levels, the Fed’s push for higher borrowing costs may finally be restricting demand for workers in these areas.

The levels of hires, quits and layoffs (collectively known as separations) were little changed from July.

The quits rate (a percentage of total employment in the month), a proxy for confidence in the market was steady at 2.8%.

Source: US BLS

From a bird’s eye view, 1.7 openings were available for each unemployed person, cooling from 2.0 in the month prior but still above the historic average. 

The market still appears favourable for workers but seems to have begun showing signs of fatigue.

Ian Shepherdson, Economist at Pantheon Macroeconomics noted that it was too soon to suggest if a new trend had started to emerge, and said,

…this is the first official indicator to point unambiguously, if not necessarily reliably, to a clear slowing in labour demand.

Nick Bunker, Head of Economic Research at Indeed, also stated,

The heat of the labour market is slowly coming down to a slow boil as demand for hiring new workers fades.

Ironically, equities surged as investors pinned their hopes on weakness in headline jobs numbers being the sign of breakage the Fed needed to pull back on its tightening.

Kristen Bitterly, Citi Global Wealth’s head of North American investments added,

(In the past, in) 8 out of the 10 bear markets, we have seen bounces off the lows of 10%…and not just one but several, this is very common in this type of environment.

The worst may be yet to come

As for the health of the economy, after much seesawing in its projections, which swung between 0.3% as recently as September 27 and as high as 2.7% just a couple of weeks earlier, the Atlanta Fed GDPNow estimate was finalized at a sharply rebounding 2.3% for Q3, earlier in the week.

Rod Von Lipsey, Managing Director, UBS Private Wealth Management was optimistic and stated,

…looking for a stronger fourth quarter, and traditionally, the fourth quarter is a good part of the year for stocks.

As I reported in a piece last week, a crucial consideration that has been brought up many a time is the unknown around policy lags.

Cathie Wood, Ark Invest CEO and CIO noted that the Fed has increased rates an incredible 13-fold in a span of just a few months, which is in stark contrast to the rate doubling engineered by Governor Volcker over the span of a decade.

Pedro da Costa, a veteran Fed reporter and previously a fellow at the Peterson Institute for International Economics, emphasized that once the Fed tightens policy, there is no way to know when this may be fully transmitted to the economy, which could lie anywhere between 6 to 18 months.

The JOLTs report reflects August data while the Fed has continued to tighten. This raises the probability that the Fed may have already done too much, and the environment may be primed to send the jobs market into a tailspin.

Several recent indicators suggest that the labour market is getting ready for a significant deceleration.

For instance, new orders contracted aggressively to 47.1. Although still expansionary, ISM manufacturing data fell sharply to 50.9 global, factory employment plummeted to 48.7, global PMI receded into contractionary territory at 49.8, its lowest level since June 2020 while durable goods declined 0.2%.

Moreover, transpacific shipping rates, a leading indicator absolutely crashed, falling 75% Y-o-Y on weaker demand and overbought inventories.

Steven van Metre, a certified financial planner and frequent collaborator at Eurodollar University, argued

“…the next thing to go is the job market.“

A recent study by KPMG which collated opinions of over 400 CEOs and business leaders at top US companies, found that a startling 91% of respondents expect a recession within the next 12 months. Only 34% of these think that it would be “mild and short.”

More than half of the CEOs interviewed are looking to slash jobs and cut headcount.

Similarly, a report by Marcum LLP in collaboration with Hofstra University found that 90% of surveyed CEOs were fearful of a recession in the near future.

It also found that over a quarter of company heads had already begun layoffs or planned to do so in the next twelve months.

Simply put, American enterprises are not buying the Fed’s soft-landing plans.

A slew of mass layoffs amid overwhelming inventories and a weak consumer impulse will result in a rapid decline in price pressures, exacerbating the threat of too much tightening.

Upcoming data

On Friday, the markets will be focused on the BLS’s non-farm payrolls data. Economists anticipate a comparatively small addition of jobs, likely to be near 250,000, which would mark the smallest monthly increase this year.

In a world where interest rates are still rising, demand is giving way, the prevailing sentiment is weak and companies are burdened by excessive inventories, can job cuts be far behind?

The post JOLTs jolted: Did the Fed break the labour market? appeared first on Invezz.

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International

Trade Deficit decreased to $67.4 Billion in August

From the Department of Commerce reported:The U.S. Census Bureau and the U.S. Bureau of Economic Analysis announced today that the goods and services deficit was $67.4 billion in August, down $3.1 billion from $70.5 billion in July, revised.August exp…

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From the Department of Commerce reported:
The U.S. Census Bureau and the U.S. Bureau of Economic Analysis announced today that the goods and services deficit was $67.4 billion in August, down $3.1 billion from $70.5 billion in July, revised.

August exports were $258.9 billion, $0.7 billion less than July exports. August imports were $326.3 billion, $3.7 billion less than July imports.
emphasis added
Click on graph for larger image.

Exports increased and imports decreased in August.

Exports are up 20% year-over-year; imports are up 14% year-over-year.

Both imports and exports decreased sharply due to COVID-19 and have now bounced back.

The second graph shows the U.S. trade deficit, with and without petroleum.

U.S. Trade Deficit The blue line is the total deficit, and the black line is the petroleum deficit, and the red line is the trade deficit ex-petroleum products.

Note that net, imports and exports of petroleum products are close to zero.

The trade deficit with China increased to $37.4 billion in August, from $21.7 billion a year ago.

The trade deficit was slightly lower than the consensus forecast.

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