It is a distinct possibility that the next few months will see the advent of an effective vaccine for Covid-19. It is therefore vital that technologies exist to track any vaccine’s long-term effects in terms of immunity to reinfection. With this in mind Siemens Healthineers has today CE marked and launched in Europe its COV2G antibody test for the expanded use of reporting quantitative levels of neutralising antibodies in a patient’s blood sample. Healthineers has also filed for a US EUA for this new use – if this succeeds the assay would be the second authorised by the FDA specifically to detect neutralising antibodies, but the first to do so quantitatively. COV2G launched in summer as a semi-quantitative test, able to estimate antibody levels, but can now measure them directly. Repeated testing can thus give an insight into how well a patient might be able to repel subsequent Covid-19 infections. Doing this on a population level will help inform whether broad vaccination programmes are working. Speaking on a conference call today, Deepak Nath, president of laboratory diagnostics at Healthineers, said that the pricing of the assay would depend on individual contracts with suppliers, but would be competitive with other antibody tests.
Wednesday, November 18, 2020
Pfizer and Biontech’s Covid-19 vaccine overdelivers
In the end Pfizer and Biontech need not have played it safe. Final readout of the pivotal trial of their Covid-19 vaccine BNT162b2 has shown 95% efficacy, in line with the 94.5% cited at the first interim analysis of their rival Moderna’s mRNA-1273. First interim readout had shown BNT162b2 to be “more than 90% effective”, the vagueness widely assumed to be down to the companies’ desire not to overpromise on the final result. While the important thing now is that both projects are similarly efficacious, investors will note that one of the eight Covid-19 infections in BNT162b2-treated volunteers was severe, versus none in the five cases seen with mRNA-1273, and will point to the different time frames the two trials use for determining efficacy. Only a long-term readout will enable like-for-like comparisons – for safety and efficacy alike. Despite the positive result Biontech did not recover Monday’s losses this morning, presumably owing to a possible convenience advantage for mRNA-1273, which was said to remain stable at standard refrigerator temperatures for 30 days, versus seven days previously. The Moderna trial is itself very close to its final readout, which will be triggered by 151 Covid-19 infections.
| Company | Biontech/Pfizer | Moderna |
| Project | BNT162b2 | mRNA-1273 |
| Pivotal study | NCT04368728 | Cove |
| Dosing | Day 0 & day 21 | Day 0 & day 28 |
| Readout timing | Day 28 | Day 42 |
| Enrolment | 43,538 | 30,000 |
| Cases in active cohort | 8 (1 severe) | 5 (0 severe) |
| Cases in placebo cohort | 162 (9 severe) | 95 (11 severe) |
| Efficacy | 95% | 94.5% |
| Manufacturing capacity 2020 | 50m doses | 20m doses |
| Manufacturing capacity 2021 | 1.3bn doses (250m in H1) | 500m to 1bn doses |
Source: company announcements & Evercore ISI. | ||
'FDA: coronavirus vaccine reviews will take weeks, not days'
As leading COVID-19 vaccines post positive phase 3 data and near FDA submissions, the agency official in charge of reviewing vaccines is emphasizing transparency and patience during the high-stakes process.
Americans should expect reviews to take weeks rather than days, Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, told Business Insider. While the dire COVID-19 pandemic naturally creates urgency, Marks and his team "have to take the amount of time that we need to take," he said. The FDA is said to be discussing potential committee meetings for December 8 to 10, CNBC's Meg Tirrell reports.
"What we need here is confidence," Marks told BI. "Everything that we are trying to do here, this is all about ensuring the public re-develops the kind of trust they once had in vaccines."
Toward that goal, as the leading candidates move to the regulatory stage, Americans can expect a “very open process," he said.
His remarks come as Pfizer and its partner BioNTech finished their large phase 3 trial, reporting 95% efficacy and no serious safety concerns for their mRNA vaccine. Each vaccine that comes under review at the agency will have a separate public hearing to closely scrutinize the data, officials have said.
Following their trial, Pfizer and BioNTech plan to seek an emergency use authorization “within days.”
As the FDA's top vaccines official, Marks has made headlines before during the COVID-19 pandemic. He’s previously said he’d retire if any outsiders tried to exert force on his organization’s review processes, and again made that commitment in his BI interview. Previously, Marks told Fierce Pharma it's his job to allow "the process to take place ... free of distractions from factors that aren’t related to quality, safety or efficacy of the vaccine."
In addition to the FDA’s rigorous review process, the CDC’s Advisory Committee on Immunization Practices typically takes a deep look into vaccine data and makes recommendations about who should receive vaccines.
Pfizer isn’t alone in nearing a potential EUA submission. Moderna this week revealed its vaccine was 94.5% effective in an interim analysis. The company intends to submit the data to the FDA “in the coming weeks.” Aside from those programs, Johnson & Johnson, AstraZeneca and Novavax are in phase 3, and a host of other players are in earlier stages of testing.
https://www.fiercepharma.com/pharma/as-covid-vaccine-developers-post-impressive-data-fda-official-says-reviews-will-take-weeks
Pfizer: 3.8% of trial participants felt fatigue after 2nd jab
Pfizer Inc on Tuesday updated its analysis of the safety profile of its COVID-19 vaccine seen during its large, late-stage trial, saying that 3.8% of participants experienced fatigue after receiving a second dose of the shot.
It said the updated analysis was based on 8,000 trial participants. Pfizer said in a previous analysis that 3.7% of 6,000 volunteers had experienced fatigue.
Pfizer also added that there was a second adverse event with a frequency of at least 2% in the trial. The U.S. drugmaker said 2% of participants experienced headaches after the second shot.
BioNTech CEO: vaccine approval possible in mid-December in ideal conditions
U.S. and European regulators could approve Pfizer and BioNTech’s experimental COVID-19 vaccine as early as mid-December, the German firm’s chief executive said on Wednesday, following the release of positive trial results.
Speaking to Reuters TV, Chief Executive Ugur Sahin said if all goes well, the U.S. Food and Drug Administration could grant emergency-use approval towards the end of the first half of December or early in the second half.
Conditional approval in the European Union could be achieved in the second half of December, he added.
“It will depend on the requests that we will receive and whether all the conditions are met.”
Can first COVID-19 vaccines bring herd immunity?
Governments and officials are voicing hopes that COVID-19 vaccines could bring “herd immunity”, with some calculating that immunising just two-thirds of a population could halt the pandemic disease and help protect whole communities or nations.
But the concept comes with caveats and big demands of what vaccines might be capable of preventing. Some experts say such expectations are misplaced.
For a start, figuring out what’s needed to achieve herd immunity with COVID-19 vaccines involves a range of factors, several of which are unknown.
What is the rate of the spread of the COVID-19-causing virus? Will the first vaccines deployed be able to stop transmission of the virus, or just stop people getting ill? How many people in a population will accept a vaccine? Will vaccines offer the same protection to everyone?
“Herd immunity is sometimes wrongly understood as individual protection,” said Josep Jansa, an expert in health emergency preparedness and response at the Stockholm-based European Centre for Disease Prevention and Control (ECDC).
“It’s inappropriate to think ‘I will not be affected myself because there is herd immunity’. Herd immunity refers to community protection, not to how an individual is protected.”
The ECDC uses an estimated herd immunity threshold of 67% for its models, while Chancellor Angela Merkel said this month that COVID-19 restrictions in Germany could be lifted if 60% to 70% of the population acquired immunity, either via a COVID-19 vaccine or through infection.
World Health Organization experts have also pointed to a 65%-70% vaccine coverage rate as a way to reach population immunity through vaccination.
“The idea of herd community is to protect the vulnerable,” said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh. “And the idea behind it is that if, say, 98% of a population have all been vaccinated, there will be so little virus in the community that the 2% will be protected. That’s the point of it.”
REPRODUCTION RATE IS CRUCIAL
Central to the public health calculations on this concept for COVID-19 is the reproduction rate, or R value, of the virus that causes it. This is a measure of how many other people an average infected person passes a pathogen on to in “normal”, or restriction-free, circumstances.
Assuming complete vaccine efficacy, herd immunity percentage thresholds for infectious diseases are calculated by dividing 1 by the R value, deducting the result from 1, and multiplying by 100.
For instance, herd immunity from highly contagious measles, with an estimated R value of 12 or higher, will kick in only if 92% or more within a group are immune. For a seasonal flu strain that could have an R value of 1.3, the threshold would be just 23%.
“The problem is that for now we don’t know exactly how fast the virus spreads without any precautions and with the normal travel and social activities we had a year ago,” said Winfried Pickl, professor of immunology at the Medical University of Vienna.
With so many countries still operating in far from normal circumstances, the assumption should be that the COVID-19 R value would be “closer to 4 than to 2”, he said, since even with semi- or full lockdown measures the R value is around 1.5.
Additionally, anything less than 100% vaccine efficacy - such as the 90% or so suggested in early data on the Pfizer-BioNTech and Moderna COVID-19 shots - would require a matching rise in percentage of coverage to reach herd threshold.
Amesh Adalja, a scholar at the Johns Hopkins Center for Health Security, said a good target for immunity in the United States would be for more than 70% of the population to be inoculated, but added that the figure could go up if vaccines are less effective.
STOP TRANSMISSION IN THE “HERD”?
Experts say another important factor is whether the COVID-19 vaccines a government chooses to deploy can stop transmission of the virus.
Evidence so far suggests the first COVID-19 vaccines to come to market will at least stop people developing the disease. But it cannot be ruled out that people will still catch the SARS-CoV-2 virus and pass it on to others unnoticed.
“While protection against illness has a value for an individual, it will not prevent circulation of virus and risk of disease in unvaccinated (people),” said Penny Ward, a visiting professor in pharmaceutical medicine at King’s College London.
Bodo Plachter, a professor and deputy director of the Institute of Virology at Germany’s Mainz University teaching hospital, said that respiratory infections in particular can be hard to block completely with vaccines - although the shots will go some way to reducing the amount of circulating virus.
“It may well be that vaccinated people will shed fewer viruses,” he said. “But it would be a mistake to assume vaccination alone can suppress a pandemic.”
FOCUS ON PROTECTING THE VULNERABLE?
Edinburgh’s Riley said this suggests that for now, pursuing an idea of herd immunity through COVID-19 vaccination is fruitless.
A better approach, she said, could be to “turn herd immunity on its head”, and use the first limited supplies of vaccines to protect those most in need, without worrying about the more robust members of the “herd” who can live relatively happily with the virus.
Omeros jumps after BLA submission for respiratory med
- Omeros shares climb 7.5% after the company completes its rolling submission of its Biologics License Application to the FDA for narsoplimab for the treatment of a complication associated with stem cell transplantation.
- The company has requested priority review for the BLA, and applicable regulations provide FDA up to 60 days to determine the filing and review designation for the application.
- If the stock's advance stays at that level, it will be Omeros's largest rise since Aug. 10, when it reported positive results from a compassionate use study evaluating narsoplimab in severely ill COVID-19 patients with acute respiratory distress syndrome requiring mechanical ventilation.
- The BLA is for the use of narsoplimab in treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
- Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA.
https://seekingalpha.com/news/3637588-omeros-jumps-7_5-after-completing-bla-submission-for-narsoplimab
Subscribe to:
Posts (Atom)