Pfizer Analysts Raise Odds Of Success For Coronavirus Vaccine Candidate To 100%

Pfizer Inc. PFE 1.27% reported Monday with strong Phase 3 interim efficacy data for its coronavirus vaccine candidate.

The Pfizer Analysts: Morgan Stanley analyst David Risinger has an Equal-weight rating on Pfizer with a $42 price target. 

SVB Leerink analyst Geoffrey Porges reiterated a Market Perform rating and increased the price target from $43 to $44.

Morgan Stanley On Pfizer's Vaccine Economics, Timeline: The more than 90% efficacy with 94 cases suggests the final analysis with 164 cases will in all likelihood exceed the FDA's efficacy criteria of 50%, Risinger said in a note.

Based on this and the lack of any serious safety concerns, the analyst raised the vaccine's probability of success from 65% to 100%.

With Pfizer planning to submit emergency use authorization in the third week of November — when it has two months of median safety data — Risinger said he expects the FDA to hold a panel meeting to discuss the data by early-to-mid December.

An emergency use authorization approval for health care workers and certain high-risk populations could come by late December, he said. 

Following six months of safety data, full approval is likely to come in the spring, Risinger said. 

Morgan Stanley estimates 50% economic-adjusted and 100% risk-adjusted vaccine revenue of $488 million for Pfizer in 2020, with revenue increasing to $7.2 billion in 2021 and then moderating to $3.8 billion in 2023.

How Pfizer's High Efficacy Could Drive Early Adoption: The high vaccine efficacy and the absence of new safety signals led to SVB Leerink increasing its probability of success estimate from 80% to 100%, Porges said in a note. 

"We believe this high efficacy could drive up initial vaccine adoption, therefore our forecasts increase by 10-40% in 2022-2023," the analyst said. 

Given the likelihood of other vaccine candidates showing similar vaccine efficacy and competing for market share with lower unit prices in later years, SVB Leerink lowered its estimates for BNT162b2 by 10%-20% for 2026 and beyond.

The firm's global vaccine revenue forecast for Pfizer is at $258 million in the fourth quarter. This will increase to $4.6 billion in 2021 before declining to $2.8 billion by 2023 and plateauing between $1.2 billion and $1.6 billion in the period from 2026 to $2029, Porges said. 

Consequently, SVB Leerink ncreased its total revenue and EPS forecast for Pfizer for the period from 2022 to 2023 by 2%-3% annually. 

https://www.benzinga.com/analyst-ratings/analyst-color/20/11/18299631/pfizer-analysts-raise-odds-of-success-for-coronavirus-vaccine-candidate-to-100

Theresa May demands full release of data behind UK Covid-19 decisions

Theresa May accused Boris Johnson of choosing data to fit his coronavirus policies, as she insisted the Government must reveal the economic cost of lockdown.

The Conservative former prime minister tore into predictions said to have informed her successor’s decision to impose a second national lockdown in England, which will start on Thursday and last until December 2.

But Mr Johnson was not in the chamber to hear the criticism, as the Prime Minister opted to leave shortly after Mrs May got to her feet and acknowledged that she did not “envy” the decisions facing him and the Government.

Mr Johnson had already spent time in the chamber for Prime Minister’s Questions and decided to depart once Labour leader Sir Keir Starmer had made his speech during the debate on the new Covid-19 lockdown restrictions.

It is understood the Prime Minister later sent a note of apology to Mrs May as he had to leave the chamber to attend a scheduled meeting.

Speaking as MPs considered regulations for a second lockdown, Mrs May said: “This pandemic has challenged governments across the world and ministers have been under relentless pressure in dealing with this issue.

“But, just as ministers are making tough decisions, so are Parliament, and Parliament will make better decisions if it is fully and properly informed.”

She criticised Labour’s circuit-breaker proposal, claiming it could have ended up being repeated “again and again and again”.But she then turned her fire on the projections used by Mr Johnson.

She said: “It appears the decision to go towards this lockdown was partly, mainly, to some extent based on the prediction of 4,000 deaths a day.

“Yet, if you look at the trajectory showing in that graph that went to 4,000 deaths a day, we would have reached 1,000 deaths a day by the end of October.

“The average in the last week of October was 259, by my calculations. Each of those deaths is a sadness and our thoughts are with the families, but it’s not 1,000 deaths a day.

“So the prediction was wrong before it was even used.

“And this leads to a problem for the Government – for many people it looks as if the figures are chosen to support the policy rather than the policy being based on the figures.

“We need these proper analyses. We need to know the details behind these models. We need to be able to assess the validity of those 

Mrs May also raised concerns about a lack of data on the cost of the Government’s Covid-19 decisions, including on mental health, domestic abuse, non-Covid-19 treatments, “possibly more suicides” and to the economy.

She told MPs: “Jobs lost, livelihoods shattered, businesses failing, whole sectors damaged. What sort of airline industry are we going to have coming out of this? What sort of hospitality sector? What sort of small independent shops will be left?

“The Government must have made this analysis, made this assessment – let us see it and make our own judgments.”

On public worship, Mrs May added: “My concern is that the Government today making it illegal to conduct an act of public worship, for the best of intentions, sets a precedent that could be misused for a Government in the future with the worst of intentions.”

Sir Graham Brady, chairman of the Conservative backbench 1922 Committee, outlined his opposition to the regulations and questioned whether the Government had “any right” to take some of the measures.

He said: “The thing that troubles me most is that the Government is reaching too far into the private and family lives of our constituents. I think there is an, unintended perhaps, arrogance in assuming the Government has the right to do so.

“That it has the right to tell people whether they can visit their elderly parents in a care home, whether it has the right to tell parents they can’t see their children or grandchildren, whether it has any right – for heaven’s sake – to tell consenting adults with whom they are allowed to sleep. Does it have the right to ban acts of collective worship?”

Senior Conservative MP Sir Charles Walker added that people were being “coerced” rather than asked to follow the rules.

He said: “This legislation goes against my every instinct, perhaps an instinct even more fundamental than the love and touch of my family.”

Conservative Philip Davies (Shipley) warned that lockdowns “cost lives as well as livelihoods”, adding: “People are not stupid, they can see that the rules do not make any sense, and that is why they, like me, no longer have any faith in the people at the Department of Health and Public Health England who are making these decisions.

“I never thought I would see the day a so-called Conservative minister would stand up and urge Parliament to further sacrifice our most basic of freedoms, collapse the economy and destroy jobs – all to pursue a failed strategy.”

https://www.expressandstar.com/news/uk-news/2020/11/04/theresa-may-demands-full-release-of-data-behind-covid-19-decisions/

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Voyager Therapeutics downgraded by 2 sell siders

Nov-10-20 Downgrade Wells Fargo Overweight → Equal Weight $10 Nov-10-20 Downgrade Raymond James Strong Buy → Outperform $28 → $17 https://www.finviz.com/quote.ashx?t=VYGR

Aptevo to Present at Society for Immunotherapy of Cancer Meet

Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ bispecific technology platform, today announced that it will present two new posters at the Society for Immunotherapy of Cancer's (SITC) 35^th Virtual Annual Meeting, to be held from Monday, November 9, 2020 to Saturday, November 14, 2020.

The posters will provide updates on APVO603, which is wholly owned by Aptevo Therapeutics, and the phase 1-ready ALG.APV-527 developed in partnership with Alligator Bioscience.

The abstracts and the accompanying posters will be available in the Virtual Poster Hall to registered attendees from 8:00 am EST on Monday, November 9, until the Virtual Poster Hall closes on December 31, 2020 on the SITC abstract website. Details will also be posted on the Aptevo Therapeutics website.

https://finance.yahoo.com/news/aptevo-therapeutics-present-society-immunotherapy-140000684.html

First data hint at T-cell immunity to Covid-19

Oxford Immunotec’s test might be able to pinpoint those at low risk of reinfection. 

The good news on Covid-19 just keeps coming. The first evidence backing a link between coronavirus-reactive T cells with immunity emerged today, and while – as with the results on Pfizer and Biontech’s vaccine yesterday – more work must be done, this is a positive sign.

The data come from a prospective cohort of the UK-based Edsab-Home trial, which is evaluating a range of Covid-19 assays. Specifically the readout concerns Oxford Immunotec’s T-Spot Discovery test, and with the UK group lining up regulatory submissions this assay could become a useful tool in the fight against the virus. 

The Edsab-Home trial is a collaboration between several testing companies and Public Health England. This particular cut of the data was released as a preprint ahead of peer review.

Spot the difference

Starting in June 2020, 2,826 people working in hospitals or in the fire and police services in England – high-risk occupations during the pandemic – were enrolled into Edsab-Home and allocated to the cohort testing Oxford Immunotec's assay. 

Subjects’ baseline levels of interferon-γ secreting, Sars-Cov-2-responsive T cells were assessed using the company's T-Spot kit, which uses the company’s EliSpot technology. Enrolees were also tested for antibodies to the coronavirus using either Roche’s Elecsys anti-Sars-Cov-2 test or Euroimmun’s anti-S IgG immunoassay.

The participants were followed until mid-October, a median of 118 days. In that period none of the participants with high levels of T cells responsive to the coronavirus’s spike, nuclear and membrane (SNM) proteins developed symptomatic Covid-19 infection, whereas among those with low T-cell responses there were 20 confirmed infections. All 20 infections occurred in people who were also seronegative; that is, they did not have detectable levels of antibodies against the coronavirus. 

Statistically, Covid-19 was significantly more common in individuals with lower T-Spot SNM results over the time period studied, at p=0.001 and log-rank p=0.007. This is the first evidence that high levels of coronavirus-responsive T cells are associated with protection from symptomatic infection, Oxford Immunotec claimed.

Of the volunteers recruited irrespective of previous Covid-19 PCR test results, around a quarter had elevated levels of SNM-responsive T cells. Of these, just over half were seropositive for Covid-19 antibodies. Among seronegative individuals – those without detectable antibodies to the virus – the subjects with lower numbers of SNM-responsive T cells were also more likely to develop Covid-19, but the difference was on the border of significance, at p=0.046 and log-rank p=0.08. 

Kaplan-Meier curves in all subjects (A), or seronegative subjects (B), showing time to testing positive for Covid-19. Source: medRxiv preprint.

The researchers said that the protective association of high T-Spot SNM results in the seronegative population raised the question of whether seropositivity might appear protective in part because high antibody levels are associated with high coronavirus-responsive T-cell numbers.

Finding out how strongly T-cell responses correlate with antibody production was one of the aims of Edsab-Home, as Oxford Immunotec’s chief executive Peter Wrighton-Smith told Evaluate Vantage last month (The other kind of Covid-19 immunity, October 7, 2020).

Since in this trial the T-Spot test detected PCR-confirmed Covid-19 infections that were not positive in antibody testing, Oxford Immunotec says antibody testing alone might underestimate the working age population at lower risk of reinfection.

However, this finding does not necessarily mean that testing for reactive T cells is more accurate than antibody testing when it comes to identifying individuals who have been exposed to Covid-19. The researchers wrote that seronegative people with reactive T cells had could have had their cells primed by the virus that causes the common cold. Still, a scenario whereby the T cells were primed by minimally symptomatic Sars-Cov-2 infection, without antibody generation, cannot be excluded.

A four-month long study in fewer than 3,000 people in a single country cannot be regarded as conclusive proof that the presence of coronavirus-reactive T cells confers immunity to Covid-19. But the data certainly do not disprove that hypothesis. If the findings are not contradicted by future research, T-cell testing could become a major part of efforts to control the pandemic – and Oxford Immunotec could be in the vanguard.

https://www.evaluate.com/vantage/articles/news/trial-results/first-data-hint-t-cell-immunity-covid-19

Paris prosecutor advances criminal probe into COVID-19 crisis handling

A criminal investigation into whether the public officials who orchestrated France’s response to the COVID-19 crisis committed offences including manslaughter and endangering lives will be split into four inquiries, the public prosecutor said.

Remy Heitz said the investigation, still at a preliminary stage, would focus on the impact on the general public, healthcare workers, public servants and those who were sickened or died from COVID-19.

Two investigations are under way into France’s handling of the global pandemic, which has killed about 41,000 people in the country, roiled its economy and upended the social life of citizens.

One is the criminal investigation, opened in June and handled by the Paris public prosecutor. It is looking into whether France’s response to the crisis resulted in involuntary homicide and injury, endangering lives, and the wilful refusal to fight a disaster. No examples of the offences were given.

During the pandemic’s first wave last spring, there were many deaths in care homes where a lack of testing or protective gear meant the virus was brought in from the outside.

At this stage, no named individuals are targeted in the investigations.

The other is an inquiry led by an administrative tribunal, the Court of Justice, established in 1993 to handle cases of alleged ministerial misconduct.

In an unusual move, police last month raided the homes and offices of France’s health minister, its director of public health and the former prime minister as part of the Court of Justice’s investigation.

https://www.reuters.com/article/us-health-coronavirus-france-probe/paris-prosecutor-advances-criminal-investigation-into-covid-19-crisis-handling-idUSKBN27Q1XN

U.S. denounces terms for WHO-led inquiry into COVID origins

The United States, which has accused China of having hidden the extent of its coronavirus outbreak, called on Tuesday for a “transparent and inclusive” WHO-led international investigation into the origin of the pandemic, criticising its current terms.

The Trump administration has accused the World Health Organization of being “China-centric” and of being its puppet, which WHO director-general Tedros Adhanom Ghebreyesus has denied.

Tedros revealed the team’s composition on Tuesday, telling the WHO annual ministerial meeting: “These are very respected individuals in their areas.”

Team members came from Russia, Australia, Sudan, Denmark, the Netherlands, Germany, Japan, Vietnam, the United Kingdom and the United States, he said.

The virus, known as SARS-CoV-2, is believed to have emerged in the Chinese central city of Wuhan late last year, possibly from bats at a market with live animals.

Chinese scientists are carrying out research into its origins and how it jumped the species barrier. The WHO-led international team formed in September is to develop plans for longer-term studies building on China’s findings, according to its published terms of reference.

Garrett Grigsby, of the U.S. Department of Health and Human Services, told the WHO’s assembly that member states had been informed of the investigation’s terms of reference only a few days ago.

The terms were “not negotiated in a transparent way with all WHO member states” and “the investigation itself appears to be inconsistent” with its mandate, he said, without elaborating.

“Understanding the origins of COVID-19 through a transparent and inclusive investigation is what must be done to meet the mandate,” Grigsby said.

Britain called for prioritising the probe, adding: “We expect the investigation and its outcomes to be grounded in robust science.”

Sun Yang, of China’s National Health Commission, did not mention the investigation in his speech on Tuesday, but said that China supports “WHO’s continued leadership role”.

German Health Minister Jens Spahn, speaking for the European Union on Monday, called for “full transparency and cooperation” during all phases of the investigation.

WHO’s top emergency expert Mike Ryan said on Oct. 30 that the WHO-led team and its Chinese counterparts had held a first virtual meeting regarding joint investigations and would deploy on the ground in time.

Trump announced a temporary halt to U.S. funding to the WHO in April, prompting condemnation from many world leaders. The United Nations said in July it had received formal notification of the U.S. decision to leave the body next July.

https://www.reuters.com/article/us-health-coronavirus-who/u-s-denounces-terms-for-who-led-inquiry-into-covid-origins-idUSKBN27Q1LX