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Pfizer rolls out next-gen pneumococcal vaccine with FDA win, beating Merck’s 15-valent candidate to the punch

Merck and Pfizer have been locked in a yearslong battle for a next-gen pneumococcal vaccine winner, with the latter looking to one-up — or should we say seven-up — its standard 13-valent shot. Now, Pfizer has nosed out a win with the FDA’s backing,…

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Merck and Pfizer have been locked in a yearslong battle for a next-gen pneumococcal vaccine winner, with the latter looking to one-up — or should we say seven-up — its standard 13-valent shot. Now, Pfizer has nosed out a win with the FDA’s backing, leaving Merck and its 15-valent shot waiting in the wings.

Pfizer said on Tuesday that the FDA has approved its Prevnar 20 for adults 18 years and older — just over a month before Merck’s PDUFA date for its V114. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet in October to discuss and update recommendations on the use of pneumococcal vaccines, according to Pfizer.

“With a single injection, PREVNAR 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world,” Kathrin Jansen, SVP and head of vaccine R&D at Pfizer, said in a statement.

There are currently two main types of pneumococcal vaccine: pneumococcal conjugate vaccines (PCV) and pneumococcal polysaccharide vaccines (PPSV). Both contain polysaccharides taken from serotypes of S. pneumoniae bacteria, which cause patients’ immune systems to develop antibodies that will later recognize that polysaccharide.

Merck came out with its 23-valent PPSV, Pneumovax 23, back in 1983. However, PPSVs have been shown to have poor performance in younger children. As a solution, drugmakers have developed “conjugated” vaccines, in which the polysaccharides are attached to a carrier protein.

Pfizer got a 7-valent conjugate vaccine approved in 2000, followed by its 13-valent megablockbuster Prevnar 13 in 2010. Prevnar 20 covers all 13 strains that Prevnar 13 does, plus 8, 10A, 11A, 12F, 15B, 22F and 33F. The additional seven strains account for about 40% of all pneumococcal disease cases and deaths in the US, according to Pfizer.

Prevnar 13 raked in $5.8 billion in 2020 and was once the world’s best-selling vaccine in pre-Covid times. The follow-on won’t bring in the $26 billion that Pfizer’s Covid-19 vaccine is expected to in 2021, but Prophecy Market Insights expects the global pneumococcal vaccine market to grow from $8.1 billion in 2020 to $13.5 billion by 2030.

The vaccine was fast tracked by the FDA back in 2017, then given priority review in 2018. The FDA’s decision was based on Phase I and II data, as well as three Phase III trials that enrolled a total of 6,000 adults.

Pfizer unveiled data from one of those studies — a pivotal Phase III that enrolled 902 adults with no history of pneumococcal vaccination — back in October at IDWeek. The study compared Prevnar 20’s performance to Prevnar 13 and Pneumovax 23. All 20 serotypes induced “robust responses” across three age cohorts (18 to 49, 50 to 59, and 60 or older), according to Pfizer.

In the focus group of adults 60 and older, Prevnar 20’s response was non-inferior to all serotypes in common with Prevnar 13, and six of the seven new serotypes in common with Pneumovax 23 one month after vaccination. Serotype 8 just barely missed the non-inferiority lower bound criteria, but showed immune responses in other parameters, the company said. Immune responses to Prevnar 20 in the two younger age cohorts were non-inferior to the same vaccine’s responses in adults 60 to 64 years old.

Pfizer also read out data from infant trials (enrolling babies 42 to 98 days old), which showed a consistent safety profile compared to Prevnar 13 and immune response to all 20 serotypes one month after the third dose. Booster responses were recorded for all serotypes a month after the fourth dose.

Merck isn’t throwing in the towel just yet. Last month — even as it looked like Prevnar 20 might beat it to market — the Kenilworth, NJ-based pharma read out topline results from two Phase III pediatric studies, and said it’s on track to submit a supplementary BLA by the end of the year.

V114 covers the 13 serotypes covered by Prevnar 13, plus an additional two: 22F and 33F.

Roy Baynes

“Results from these studies support the potential of V114 to confer immunogenicity for PCV13 serotypes in infants who have previously received one or multiple doses of PCV13, and for the 15 serotypes in V114 in children in a catch-up setting,” Merck Research Labs CMO Roy Baynes said.

As Merck and Pfizer duke it out, a 24-valent candidate is in the making that hopes to topple them both. Vaxcyte, formerly known as SutroVax, is in early development with VAX-24 and expects to file an IND in the first half of 2022. The company pulled in $249 million in an IPO last June, and says a Phase I/II readout would follow between late 2022 and early 2023.

On Jan. 11 — the same day the FDA accepted a BLA for V114 — Merck filed a lawsuit challenging three of Pfizer’s patents relating to its pneumococcal conjugate compositions. The company has asked a judge to rule that V114 “does not and will not infringe any valid claim of these three patents.”

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Spread & Containment

COVID-19 may never go away, but practical herd immunity is within reach

It is unlikely that we will reach full herd immunity for COVID-19. However, we are likely to reach a practical kind of herd immunity through vaccination.

The level of immunity needed — either through vaccination or infection — for practical herd immunity is uncertain, but may be quite high. (Shutterstock)

When people say that we won’t reach “herd immunity” to COVID-19, they are usually referring to an ideal of “full” population immunity: when so many people are immune that, most of the time, there is no community transmission.

With full herd immunity, most people will never be exposed to the virus. Even those who are not vaccinated are protected, because an introduction is so unlikely to reach them: it will sputter out, because so many others are immune — as is the case now with diseases like polio and mumps.

The fraction of the population that needs to be immune in order for the population to have “full” herd immunity depends on the transmissibility of the virus in the population, and on the control measures in place.

It is unlikely we’ll reach full herd immunity for COVID-19.

For one thing, it appears that immunity to COVID-19 acquired either by vaccination or infection wanes over time. In addition, SARS-CoV-2 will continue to evolve. Over time, variants that can infect people with immunity (even if this only results in mild disease) will have a selective advantage, just as until now selection has mainly favoured variants with higher transmission potential.

Electron micrograph of a yellow virus particle with green spikes, against a blue background.
The B.1.1.7 variant of the SARS-CoV-2 virus. Over time, variants of concern will likely continue to emerge. NIAID, CC BY

Also, our population is a composition of different communities, workplaces and environments. In some of these, transmission risk might be high enough and/or immunity low enough to allow larger outbreaks to occur, even if overall in the population we have high vaccination and low transmission.

Finally, SARS-CoV-2 can infect other animals. This means that other animal populations may act as a “reservoir,” allowing the virus to be reintroduced to the human population.

Practical herd immunity

Nonetheless, we are likely to reach a practical kind of herd immunity through vaccination. In practical herd immunity, we can reopen to near-normal levels of activity without needing widespread distancing or lockdowns. This would be a profound change from the situation we have been in for the past 18 months.

Practical herd immunity does not mean that we never see any COVID-19. It will likely be with us, just at low enough levels that we will not need to have widespread distancing measures in place to protect the health-care system.


Read more: COVID-19 variants FAQ: How did the U.K., South Africa and Brazil variants emerge? Are they more contagious? How does a virus mutate? Could there be a super-variant that evades vaccines?


What level of immunity (either through vaccination or infection) we need for practical herd immunity is uncertain, but it may be quite high. The original strain of SARS-CoV-2 was highly transmissible and transmission is thought to be higher still for some variants of concern.

Empty vials of Pfizer's COVID-19 vaccine
To achieve two-thirds immunity, 90 per cent of the eligible population would need to be vaccinated or infected naturally. (AP Photo/John Locher)

The amount of immunity we need will also depend on what level of controls we are willing to maintain indefinitely. Continued masking, contact tracing, symptomatic and asymptomatic testing and outbreak control measures will mean we will require less immunity than we would without these in place.

Some estimates suggest that we may need two thirds of the population to be protected either by successful vaccination or natural infection. If 90 per cent of the population is eligible for vaccination, and vaccines are 85 per cent effective against infection, we can obtain this two thirds with about 90 per cent of the eligible population being vaccinated or infected naturally.

The United Kingdom has already exceeded these rates in some age groups. Higher rates are even better, because there is still uncertainty about the level of transmissibility and vaccine efficacy against infection (although research shows they are very good against severe disease). We don’t want to discover that we do not have enough immunity through vaccination and have another serious wave of infection.

Emerging variants

A sticker reading 'I'm COVID-19 vaccinated' from Vancouver Coastal Health
Booster vaccinations will hopefully allow us to maintain long-term practical herd immunity against future variants of COVID-19. THE CANADIAN PRESS/Jonathan Hayward

Higher vaccine uptake will mean there are fewer infections before we reach practical herd immunity. The remaining unvaccinated individuals will be safer, protected indirectly by the immunity of those around them. Outbreaks will be smaller and rarer, and there will be fewer opportunities for vaccine escape variants to arise and spread.

That said, variants of SARS-CoV-2 will continue to emerge, and selection will favour variants that escape our immunity. Vaccine developers will continue to broaden the spectrum of the vaccines that are available, and boosters will hopefully allow us to maintain long-term practical herd immunity.

It’s possible that an immune escape variant will emerge that is severe enough, and transmissible enough, that it will cause a new pandemic for which we do not have even practical herd immunity. But barring that, while we may not be free of COVID-19, we can be confident that in the not-too-distant future it will be manageable when we return to near-normal life.

Caroline Colijn's research group receives funding from the Natural Sciences and Engineering Research Council of Canada, Genome British Columbia, the Michael Smith Foundation for Health Research, the Public Health Agency of Canada and Canada 150 Research Chair program of the Federal Government of Canada.

Paul Tupper's research group receives funding from the Natural Sciences and Engineering Research Council of Canada.

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Stocks

Citadel Settles Suit Alleging Former Senior Trader Shared Its Algorithmic “Secret Sauce”

Citadel Settles Suit Alleging Former Senior Trader Shared Its Algorithmic "Secret Sauce"

Citadel has reached a settlement with the British hedge fund it accused of trying to plunder one of its senior traders in an effort to get to its algorit

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Citadel Settles Suit Alleging Former Senior Trader Shared Its Algorithmic "Secret Sauce"

Citadel has reached a settlement with the British hedge fund it accused of trying to plunder one of its senior traders in an effort to get to its algorithmic "secret sauce".

GSA Capital Partners LLC and Citadel announced the settlement late last week after Citadel accused the fund of obtaining "closely guarded" trading strategies when it hired the employee in question, Vedat Cologlu, according to Bloomberg. 

GSA said of the settlement that the two firms “recognize and respect the importance and value of the other’s rights over their confidential information and intellectual property.”

We first documented that Citadel was suing British hedge fund GSA Capital in January of 2020, after GSA attempted to hire Cologlu, allegedly in hopes of accessing the quant secrets at the core of Citadel's "ABC" automated trading strategy. 

Recall, we wrote back in November of 2020 that Citadel was seeking around $40 million over claims that GSA was able to obtain information on the strategy via texts and WhatsApp.

Citadel argued late last year that GSA "can't unsee" and can't forget the information that was taken from Citadel's secret algorithm. Citadel is also moving to try and block GSA from using their trading model. GSA has argued that they found no "secret sauce" from a high-level description of the structure of a trading algorithm. 

David Craig, a lawyer for Citadel Securities, said in late 2020: “GSA’s most senior managers now know where and how Citadel makes hundreds of millions of dollars in annual revenues. They cannot forget that information, or put it out of their minds.”

He noted that only 15 of Citadel's 3,000 employees ever had access to the "strategic logic" of the strategy. One of those employees was Cologlu, a 2007 Wharton grad and self-described "stat arb trader", who helped operate and administer the models whose "returns were notably high given the low level of risk it took on."

Citadel has claimed its "ABC" quant strategy cost more than $100 million to develop. In its lawsuit, Citadel alleged that the UK fund wanted Cologlu to hand over confidential information about the strategy:

GSA asked for sensitive information on his equity-trading including his profits and the speed of the trades. And then Cologlu handed over a plan that Citadel argues was based on its own confidential model, including the way the algorithm made predictions.

And there's good reason for the information to be coveted. Citadel Securities has been wildly profitable: the company posted a record $6.7 billion in revenue in 2020. This was almost double the previous high in 2018. The blockbuster result came after some of its traders moved from Chicago and New York to set up shop in a Palm Beach hotel in late March 2020 as the pandemic upended lives and markets across the globe. The results of the privately-held company were released in presentation to investors as part of a $2.5 billion loan Citadel Securities was seeking.

The Citadel securities trading arm started as a high-frequency market-maker in options before pushing into equities. Today, the firm dominates that realm and has had a very close relationship with the likes of the millennials' favorite trading platform, Robinhood. We documented back in September 2020 that Citadel now controls 41% of all retail trading. 

GSA was spun out of Deutsche Bank AG in 2005 and manages around $7.5 billion. Citadel’s legal filing names GSA founder and majority owner Jonathan Hiscox as a defendant, alongside other officials including the chief technology officer.

Back in January 2020, we noted the full details of Citadel's lawsuit. 

Tyler Durden Sat, 06/12/2021 - 14:00

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UK Government Adviser Says Mask Mandates Should Continue “Forever”

UK Government Adviser Says Mask Mandates Should Continue "Forever"

Authored by Paul Joseph Watson via Summit News,

A UK government adviser and former Communist Party member Susan Michie says that mask mandates and social distancing should…

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UK Government Adviser Says Mask Mandates Should Continue "Forever"

Authored by Paul Joseph Watson via Summit News,

A UK government adviser and former Communist Party member Susan Michie says that mask mandates and social distancing should continue “forever” and that people should adopt such behaviour just as they did with wearing seatbelts.

Michie, who is a Professor of Health Psychology at UCL and a leading member of SAGE, said such control measures should become part of people’s “normal” routine behaviour.

"Vaccines are a really important part of pandemic control but it is only one part. [A] test, trace and isolate system, [as well as] border controls, are really essential. And the third thing is people’s behaviour. That is, the behaviour of social distancing, of… making sure there’s good ventilation [when you’re indoors], or if there’s not, wearing face masks, and [keeping up] hand and surface hygiene."

"We will need to keep these going in the long term, and that will be good not only for Covid but also to reduce other [diseases] at a time when the NHS is [struggling]… I think forever, to some extent…"

"I think there’s lots of different behaviours that we have changed in our lives. We now routinely wear seatbelts – we didn’t use to. We now routinely pick up dog poo in the parks – we didn’t use to. When people see that there is a threat and there is something they can do to reduce that [to protect] themselves, their loved ones and their communities, what we have seen over this last year is that people do that."

Michie’s comments once again emphasize how many scientific advisers have become drunk on COVID-19 power and never want to relinquish it.

“Unsurprisingly, Channel 5 News made absolutely no effort to scrutinise these claims. The programme’s presenter raised no objection to the idea that mask-wearing and social distancing could continue “forever”, resorting only to friendly laughter,” writes Michael Curzon.

“Professor Michie’s co-panellist, a fellow scientist at UCL, Dr Shikta Das, said:

“I think Susan has made a very good point here,” adding that the vaccine roll-out has created a “false sense of security”.

She concluded:

“I don’t think we are yet ready to unlock.”

How’s all that for balance!

Perhaps unsurprisingly, Michie is known to be a long-time Communist hardliner and was so zealous in her beliefs she garnered the nickname “Stalin’s nanny.”

Her sentiment echoes that of fellow government adviser Professor Neil Ferguson, who once acknowledged that he was surprised authorities were able to “get away with” the same draconian measures that Communist China imposed at the start of the pandemic.

“[China] is a communist one-party state, we said. We couldn’t get away with [lockdown] in Europe, we thought… and then Italy did it. And we realised we could,” said Ferguson.

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Tyler Durden Sat, 06/12/2021 - 11:30

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