COVID-19 infection gives some immunity, but virus can still be spread: study

  People who have had COVID-19 are highly likely to have immunity to it for at least five months, but there is evidence that those with antibodies may still be able to carry and spread the virus, a study of British healthcare workers has found.

Preliminary findings by scientists at Public Health England (PHE) showed that reinfections in people who have COVID-19 antibodies from a past infection are rare - with only 44 cases found among 6,614 previously infected people in the study.

But experts cautioned that the findings mean people who contracted the disease in the first wave of the pandemic in the early months of 2020 may now be vulnerable to catching it again.

They also warned that people with so-called natural immunity - acquired through having had the infection - may still be able carry the SARS-CoV-2 coronavirus in their nose and throat and could unwittingly pass it on.

“We now know that most of those who have had the virus, and developed antibodies, are protected from reinfection, but this is not total and we do not yet know how long protection lasts,” said Susan Hopkins, senior medical adviser at PHE and co-leader of the study, whose findings were published on Thursday.

“This means even if you believe you already had the disease and are protected, you can be reassured it is highly unlikely you will develop severe infections. But there is still a risk you could acquire an infection and transmit (it) to others.”

Experts not directly involved in the research, which is known as the SIREN study, urged people to note its key findings.

“These data reinforce the message that, for the time being, everyone is a potential source of infection for others and should behave accordingly,” said Eleanor Riley, a professor of immunology and infectious disease at Edinburgh University.

Simon Clarke, an associate professor in cellular microbiology at Reading University, said the study “has major implications for how we can get out of the current crisis”.

“This means that the vast majority of the population will either need to have natural immunity or have been immunised for us to fully lift restrictions on our lives, unless we are prepared to see many more people being infected and dying from COVID-19,” he said.

PHE said in a statement that the study had not been able to explore antibody or other immune responses to the COVID-19 vaccines being rolled out in Britain. Vaccine effects would be studied as part of SIREN later this year, it said.

The SIREN study involves tens of thousands of healthcare workers in Britain who have been tested regularly since June for new COVID-19 infections as well as for the presence of antibodies.

Between June 18 and Nov. 24, scientists found 44 potential reinfections - two “probable” and 42 “possible” - among 6,614 participants who had tested positive for antibodies. This represents an 83% rate of protection from reinfection, they said.

The researchers said they would continue to follow the participants to see if this natural immunity might last longer than five months in some. But they said early evidence from the next stage of the study suggested some people with immunity could still carry high levels of virus.

https://www.reuters.com/article/us-health-coronavirus-immunity/covid-19-infection-gives-some-immunity-but-virus-can-still-be-spread-study-finds-idUSKBN29J004

Serum Institute expects WHO emergency approval for AstraZeneca shot soon

 

The Serum Institute of India (SII) expects WHO emergency use authorization soon for the Oxford University/AstraZeneca coronavirus vaccine, which it is producing for mid and low income countries, its chief executive said.

The World Health Organization (WHO) listed Pfizer and BioNTech's COVID-19 shot for emergency use on Dec. 31 as it sought to accelerate vaccination in the developing world, which is badly lagging western countries.

"The emergency use licensure from the WHO should be available and coming through in the next week or two, hopefully, because we have submitted everything," Adar Poonawalla said of the AstraZeneca/Oxford vaccine at the Reuters Next conference.

Poonawalla said SII, the world's biggest vaccine maker, was trying to begin supplies to the WHO-backed COVAX initiative by the end of January. It is selling each dose at $3 for low-income countries and at a "slightly higher" price for others.

Some 189 countries have joined the programme, which was established to ensure equitable distribution of vaccines.

From sending about 20 million doses for the initiative in February, SII will raise this to 50 million per month from around April, while simultaneously selling 30-40 million doses each month to India, Poonawalla added on Thursday.

SII has already sold 11 million doses to the government, which is due to begin a mass vaccination campaign on Saturday.

'UNIQUE POSITION'

Poonawalla said SII would start stockpiling "upwards of 40-50 million doses per month" of the Novavax coronavirus vaccine candidate from around April.

He said his family owned company, which was founded by his father Cyrus Poonawalla in 1966, is well placed to distribute 1 billion doses of vaccines this year, with COVAX having an option to buy 450 million each of the AstraZeneca and Novavax vaccines.

Apart from Brazil and Bangladesh, which are expected to soon get supplies of the AstraZeneca shot from SII, Poonawalla said the Pune-based firm has also been approached by Morocco, South Africa and Saudi Arabia.

As demand for vaccines booms, a so-called special purpose vehicle housing SII's pandemic-related products should now be valued at $12 billion to $13 billion, SII's CEO added.

"We are in a unique position to be able to make so many different vaccines at a huge volume and capacity. For an investor to come in an at a $12-13 billion valuation, it will be a fantastic deal, leaving a lot of upside."

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Serum-Institute-expects-WHO-emergency-approval-for-AstraZeneca-shot-soon-32194168/

Novartis Gets FDA Breakthrough-Therapy Designation for Ligelizumab

 Novartis AG on Thursday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to ligelizumab for the treatment of the skin disease chronic spontaneous urticaria in patients who have an inadequate response to H1-antihistamine treatment.

The Swiss drug maker said there are currently limited approved therapies for patients with chronic spontaneous urticaria, also known as chronic idiopathic urticaria, an unpredictable and severe skin disease that affects 0.5% to 1% of the global population at any time.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Novartis said it expects to file for U.S. approval of ligelizumab in chronic spontaneous urticaria in 2022.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-Gets-FDA-Breakthrough-Therapy-Designation-for-Ligelizumab-32195084/

Data fuel debate on whether J&J’s one-dose Covid vaccine will measure up

 Johnson & Johnson published updated early data on its Covid-19 vaccine Wednesday, showing that it provided participants in a clinical trial with at least some immunity after one dose.

The data, published in the New England Journal of Medicine, offer only hints to a tantalizing question: Could the vaccine, given as a single shot, perform as well as the vaccines that U.S. regulators have already authorized, which are given as two?

In the study, participants had neutralizing antibodies, measured in a unit called a geometric mean titer, of 224 to 354, on day 29 after their first vaccine dose; those levels reached 288 to 488 by day 57. These levels could be enough to produce immunity. But there was a big benefit to giving the participants a booster dose. It doubled or tripled their levels of neutralizing antibodies. The question is whether the antibody levels induced by the first dose are indeed enough, or if there are other types of immunity spurred by the vaccine that lead to protection.

“Just because it’s higher in neutralizing response doesn’t necessarily mean it’s more efficacious,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “It may be that the immune response induced by the first dose is enough and that more is not necessarily better.”

The answer to the question, of course, will come from Phase 3 clinical trial results. Said Carlos del Rio, a distinguished professor of medicine at the Emory University School of Medicine: “The proof is in the pudding.”

A third authorized vaccine — and one that could be given in a single dose — could help reshape the fight against the Covid-19 pandemic, even if supplies are expected to be limited for some time.

“Part of the complication we have is this two-dose deal,” del Rio said. “If we can have a vaccine that is a single dose, the J&J vaccine would become, without doubt, the vaccine of choice for the world.”

There are two Phase 3 studies running. A 40,000-volunteer study of the one-dose vaccine, conducted in the U.S., is set to read out in the next two weeks. A second, equally big study is being conducted using the same vaccine given as two doses, each administered 57 days apart, in case the vaccine does not prove effective in a one-dose regimen or there are other advantages, such as the durability of the vaccine, to giving a second dose.

A previous version of the paper published in NEJM was released in September on a preprint server, meaning it had not been peer-reviewed. But there are new data on the safety and durability of the vaccine in the current paper, which includes information on the safety of the shot, the duration of immune responses, and the effect of adding a second dose to the first.

Del Rio is optimistic. He points out that after one dose of the current vaccines — one made by Pfizer and its partner, BioNTech, and another made by Moderna — only 60% of participants appeared to have neutralizing antibody levels against SARS-CoV-2, the virus that causes Covid-19. With J&J vaccine data in NEJM, he said, that figure appears to be 90%. Del Rio was an investigator in the Moderna trial.

But Anna Durbin, a professor at the Johns Hopkins Bloomberg School of Public Health, was less confident about  the levels of protection. In particular, she was skeptical a one-dose vaccine would be enough for older adults, who don’t always mount as strong an immune response as younger people.

“I think it was a bit of a gamble to go with the single dose, and I think it was very responsible of the company to look at a two-dose regimen and a one-dose regimen,” said Durbin, an investigator in trials of the Pfizer vaccine and another testing a vaccine made by AstraZeneca.

Johan Van Hoof, the global head of J&J’s vaccine division, said that both animal data, which had shown strong protection based on a single dose, and data made available on Wednesday, had given J&J confidence to attempt a one-dose trial. But part of the reason, he said, was the need for a one-dose vaccine in a pandemic.

The World Health Organization, Van Hoof said, points out that the ideal profile of a pandemic vaccine is different from one during normal times.

“The difference there is that for use in an epidemic setting, where you go for the [largest] vaccination campaign, there are huge advantages in going with a single dose, even if there will eventually be some trade-off eventually in terms of durability or protection,” Van Hoof said.

If the trial result, expected in the next few weeks, is positive, the data will be submitted to the Food and Drug Administration, setting up a possible emergency use authorization in February. But then there will be the question of how fast the vaccine can be manufactured. On Tuesday, on a call with reporters, Moncef Slaoui, the outgoing head of the government’s Operation Warp Speed program, said the ramp-up could take time.

He said there would be “single digit million” doses available in the second half of February, and that efforts were being made to make that number higher. There would more in March, and much more in April, Slaoui predicted.

Johnson & Johnson said that, without regulatory approval, it was too soon to offer month-by-month estimates on the number of doses available.

“We have begun production of our vaccine candidate and are confident in our ability to meet our 2021 supply commitments signed with governments, and we expect to share more detail after some of these steps are achieved,” the company said in a statement.

https://www.statnews.com/2021/01/13/data-fuel-debate-over-whether-jjs-one-dose-covid-vaccine-will-measure-up/

Innovation Pharma Treatment for COVID-19 Receives FDA Fast Track

  Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval.

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”

To date, Brilacidin has received Fast Track designation for three different clinical indications: COVID-19, Oral Mucositis, and Acute Bacterial Skin and Skin Structure Infection (qualifying for Fast Track under Qualified Infectious Disease Product designation).

https://www.globenewswire.com/news-release/2021/01/14/2158550/0/en/Innovation-Pharmaceuticals-Brilacidin-for-the-Treatment-of-COVID-19-Receives-FDA-Fast-Track-Designation.html

Bicycle Therapeutics Updates Pipeline Progress

- BT1718 progressing in Cancer Research UK sponsored Phase IIa clinical trial

- Phase I trial of BT5528 currently dosing within predicted therapeutic range; preliminary signs of anti-tumor activity observed, including a partial response

- BT8009 pharmacokinetic profile consistent with preclinical predictions based on early clinical data; first clinical site outside the United States expected to open for recruitment this quarter

- BT7480 on track for Phase I trial start in 2H ’21; early immuno-oncology discovery has resulted in new programs targeting natural killer cells, which are now moving into lead optimization

https://finance.yahoo.com/news/bicycle-therapeutics-announces-pipeline-progress-120000421.html

Kaleido Bio Has Positive Interim Results with Mild-to-Moderate COVID-19

 Preliminary analysis (n=176) demonstrates favorable safety and tolerability; data provide a strong signal of clinical benefit for subjects reporting one or more comorbidities

Topline data from full study population of 350 patients and results of second study of KB109 are expected in the first quarter of 2021

https://www.globenewswire.com/news-release/2021/01/14/2158541/0/en/Kaleido-Biosciences-Announces-Positive-Interim-Results-of-Controlled-Study-of-KB109-in-Patients-with-Mild-to-Moderate-COVID-19.html