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Monday, November 2, 2020

T-cell study adds to debate over duration of COVID-19 immunity

A small but key UK study has found that “cellular immunity” to the pandemic SARS-CoV-2 virus is present after six months in people who had mild or asymptomatic COVID-19 - suggesting they might have some level of protection for at least that time.

Scientists presenting the findings, from 100 non-hospitalised COVID-19 patients in Britain, said they were “reassuring” but did not mean people cannot in rare cases be infected twice with the disease.

“While our findings cause us to be cautiously optimistic about the strength and length of immunity generated after SARS-CoV-2 infection, this is just one piece of the puzzle,” said Paul Moss, a professor of haematology at Britain’s Birmingham University who co-led the study.

“There is still a lot for us learn before we have a full understanding of how immunity to COVID-19 works.”

Experts not directly involved with the study said its findings were important and would add to a growing body of knowledge about potential protective immunity to COVID-19.

The study, which has not yet been peer-reviewed by other experts but was published online on bioRvix, analysed the blood of 100 patients six months after they had had either mild or asymptomatic COVID-19. It found that while some of the patients’ antibody levels had dropped, their T-cell response - another key part of the immune system - remained robust.

“(Our) early results show that T-cell responses may outlast the initial antibody response,” said Shame Ladhani, a consultant epidemiologist at Public Health England who co-led the work.

The study also found the size of T-cell response differed, and was considerably higher in people who had had symptomatic COVID-19 than those who had no symptoms when infected.

The researchers said this could be interpreted in two ways: It is possible that higher cellular immunity might give better protection against re-infection in people who had symptoms, or equally, that asymptomatic patients are better able to fight off the virus without the need to generate a large immune response.

“These results provide reassurance that, although the titre of antibody to SARS-CoV-2 can fall below detectable levels within a few months of infection, a degree of immunity to the virus may be maintained,” said Charles Bangham, chair of immunology at Imperial College London.

“This ... bodes well for the long term, in terms of both vaccine development and the possibility of long-term protection against re-infection,” said Eleanor Riley, an immunology and infectious disease professor at Edinburgh University. She stressed, however, that “we don’t yet know whether the people in this study are protected from re-infection.”

While more than 46 million people worldwide have been infected with COVID-19, confirmed cases of re-infection are so far very rare.

https://www.reuters.com/article/us-health-coronavirus-immunity-tcells/t-cell-study-adds-to-debate-over-duration-of-covid-19-immunity-idUSKBN27I1LL

US FDA approval tracker: October

The Covid-19 pandemic saw the FDA give full approval to Gilead’s Veklury last month despite contradictory evidence of its efficacy in hospitalised patients. Sales of the drug are forecast to peak at $3bn next year according to sellside consensus from EvaluatePharma, but with Covid-19 increasingly affecting younger, healthier patients Veklury’s use could be limited. Elsewhere, Kala received the greenlight for its dry eye treatment, Eysuvis. The next hurdle for Kala will be launching during a pandemic given most patients would likely avoid in-person physician visits for non-essential treatment. Avenue Therapeutics, meanwhile, received a knockback for its intravenous version of the opioid painkiller tramadol due to safety concerns. Avenue’s shares plummeted 59% on the news. Zosano also got a complete response letter for its migraine treatment Qtrypta, a transdermal microneedle system that delivers zolmitriptan. Due to differences observed in zolmitriptan exposures in trial subjects the FDA requested a repeat bioequivalence study between three of the product lots used during development.

Notable first-time US approval decisions in October
Project Company 2026e sales by indication ($m) Outcome
Veklury
(remdesivir)
Gilead 1,729 Approved
Eysuvis Kala Pharmaceuticals 1,118 Approved
Rolontis/
eflapegrastim
Spectrum 314 Action deferred due to Covid-19 travel restrictions
Qtrypta Zosano 286 CRL
IV tramadol Avenue Therapeutics/Fortress Biotech 281 CRL
Inmazeb
(REGN-EB3)
Regeneron - Approved
Sources: EvaluatePharma & company releases.

 

October advisory committee meeting outcomes
Project Company 2026e sales by indication ($m) Outcome Vantage story
ALKS 3831 Alkermes 362 Positive Could Alkermes’ new antipsychotic punch below its weight?
AR19
(immediate release amphetamine capsule)
Arbor - Negative -
Vaccines and related biological products - NA - US panel puts the spotlight on pivotal Covid vaccine readouts
Sources: FDA ad com calendar, EvaluatePharma.

 

Supplementary and other notable approval decisions in October
Product Company Indication (clinical trial) Outcome
Keytruda Merck & Co 2nd line treatment R/R classical HL (Keynote-204 vs Seattle's Adcetris) Approved
Opdivo + Yervoy Bristol Myers Squibb Untreated unresectable malignant pleural mesothelioma (Checkmate-743) Approved
Generic Nuvaring Mayne Pharma Group Contraception CRL
Wakix Harmony Biosciences Cataplexy in adult patients with narcolepsy (Harmony  CTP, Harmony 1) Approved
Sources: EvaluatePharma & company releases.

5th largest U.S. health insurer on board with Pulmonx emphysema device

Health Care Service Corp. which operaties Blue Cross and Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas, started covering Pulmonx's (LUNG +2.5%) Zephyr Endobronchial Valve for the treatment of severe emphysema on November 1. The organization is the fifth largest health insurer in the U.S.

UK could get COVID-19 vaccines early next year, ahead of European countries

COVID-19 vaccines could be approved and available early next year in the UK ahead of European countries, after its national regulator began its own rolling reviews of shots from AstraZeneca and Moderna.

AstraZeneca has confirmed that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has begun a fast-track rolling review of its AZD1222, the COVID-19 vaccine it developed in conjunction with Oxford University.

This followed last week’s news that the MHRA has begun a parallel rolling review of a rival from Moderna.

The rolling review allows for a real-time assessment of the clinical data from clinical trials, accelerating a process that normally takes around a year to complete using the centralised European regulatory system.

Using the MHRA could allow the UK to make regulatory decisions on COVID-19 vaccines ahead of the European system, where medicines and vaccines are first reviewed by the CHMP scientific committee before being passed on to the European Commission.

The European Medicines Agency (EMA) has already announced its own fast-track rolling reviews of AZ’s vaccine and a rival from Pfizer/BioNTech, although it has not given a timeline for a regulatory decision.

But a source close to the process told pharmaphorum that it is “eminently possible” that the MHRA could reach its conclusions early next year and ahead of its European counterparts as the country reaches the end of the Brexit transition period.

A spokesperson for the MHRA confirmed this is possible and said that from 1st January, it will have new powers to approve medicines, including vaccines with “greater flexibility to do this faster, while maintaining the highest standards of safety, quality and effectiveness.”

The spokesperson said: “The MHRA will evaluate the data rigorously on the quality, safety and effectiveness of COVID-19 vaccines to reach a scientifically robust independent opinion if an earlier authorisation is necessary before the EMA authorises a product.”

“Patient safety is our top priority. The independent Commission on Human Medicines will advise the UK government on the safety, quality and effectiveness of any potential vaccine. No vaccine will be deployed in the UK unless stringent standards have been met through a comprehensive clinical trial programme”

Representatives of the MHRA used to sit on the CHMP but no longer participate as a result of Brexit, leaving the UK to make its own decisions on medicines regulation should it choose to do so.

According to the source, COVID-19 vaccines could be available in early January depending on the length of time it takes for trial data to be published and shared with regulators.

COVID vaccines are being developed at warp speed, with the development and review process that normally takes up to a decade to complete compressed into less than a year after research began at the end of January.

The MHRA’s approach to the AZ and Moderna vaccines also paves the way for similar fast reviews to rivals from the likes of Pfizer/BioNTech and Novavax, which the UK government also has on order and are reaching the end of the clinical trial process.

The news comes as the country prepares for another national lockdown, which will disrupt business and limit people’s freedoms for at least another month.

A vaccine is seen as a potential way out of the cycle of lockdowns that have already caused severe hardship across the UK, which is one of the countries worst hit by COVID-19.

An AstraZeneca spokesperson told pharmaphorum: “Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted. It is then up to the regulatory bodies to review and make approval decisions based on this data, as quickly as possible.

“The EMA announced in October that its CHMP had started a ‘rolling review’ of data for AZD1222, the first COVID-19 vaccine to be evaluated under these arrangements. We confirm the MHRA’s rolling review of our potential COVID-19 vaccine.”

https://pharmaphorum.com/news/uk-could-get-covid-19-vaccines-early-next-year-ahead-of-european-countries/

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