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Friday, July 10, 2020

WHO’s Ryan says eradication of new coronavirus is unlikely

Dr Mike Ryan, head of the World Health Organization’s emergencies programme, said on Friday it was unlikely that the new coronavirus would be eliminated.
“In the current situation it is unlikely we can eradicate this virus,” he told an online briefing from Geneva.
He said that, by extinguishing clusters of infection, the world could “potentially avoid the worst of having second peaks and having to move backwards in terms of lockdown”.

Lonza sees EPA OK ‘very soon’ for Covid-killing claims for surface disinfectants

Lonza Group AG is in the “last step” of discussions with U.S. regulators for approval to claim that its formulation is effective in killing the novel Coronavirus on surfaces, an executive at the pharmaceutical and chemical giant told Reuters.
Earlier this week, Reckitt Benckiser Group Plc became the first company to win the U.S. Environmental Protection Agency’s approval to market two of its Lysol disinfectant sprays as household COVID-19 killers.
Reuters previously reported that Reckitt had procured a strain of the virus from an independent lab, for testing. The EPA’s approval allows Reckitt to claim that Lysol can kill the novel coronavirus, or the SARS-CoV-2, on surfaces.
Ernesto Lippert, Lonza’s vice president of strategic development and advocacy, told Reuters Thursday that it, too, obtained a strain of SARS-CoV-2 and had tested a range of its formulations in approved EPA labs. He said data shows that the products could indeed kill SARS-CoV-2 on surfaces.
“We are probably be going to be the second one after Reckitt Benckiser to have a range of our products with the actual claim against SARS-CoV-2,” Lippert said, adding that Lonza is in the “last step” of the process and that “EPA’s approval is going to be very soon.”
Reuters could not independently verify Lonza’s discussions with the EPA or the timing on a possible decision by the agency.
An EPA spokesperson said on Friday Lonza was one of several companies to have submitted laboratory data against SARS-CoV-2, but declined to elaborate on the approval timeline.
Lonza is one of a few big chemical companies, along with U.S.-based Stepan Co and Pilot Chemicals, which own chemical formulations that go into many household products. The formulations typically have been pre-tested and EPA- approved for use against a variety of pathogens. Lonza’s current clients include 3M and the maker of Pine Glo kitchen and bathroom cleaner.
The EPA in March issued new guidelines, allowing hundreds of smaller companies to quickly gain regulatory approval without subjecting their products to time-consuming testing.
Applicants with data showing their products are effective against “non-enveloped” viruses won expedited approval to market their products as potentially effective against SARS-CoV-2. The EPA considers “non-enveloped” viruses to be harder-to-kill than even SARS-CoV-2, which is an “enveloped” virus.
That easing of the rules coupled with the licensing means companies can go through an accelerated EPA vetting process than the previous time frame of six months to one year for approval.
Alexandra Dapolito Dunn, assistant administrator of the EPA’s Office of Chemical Safety and Pollution Prevention, said in a statement late March that the move would allow the EPA to better protect public health by assuring the availability of surface disinfectants to use against the novel coronavirus.
“Supplemental registration is by far the easiest and quickest mechanism to get a product into the market,” said regulatory consultant Kevin Kutcel. “You just send a notification to the EPA and you can immediately get into the marketplace very, very quickly.”
Lonza’s Lippert said the company had a more than 110% spike in supplemental registrations of its formulations in the second quarter compared to the first quarter of the year. It also is currently reviewing 62 applications to license its formulas, most of which already are EPA-approved as effective against “non-enveloped” viruses.
“Normally regulators are pretty dogmatic about these things – they insist on all the testing and are pretty rigid,” said Michael Reynen, the former research head of Procter & Gamble’s surface care business in parts of Europe, the Middle East and Africa. “But now the situation out there is pretty desperate.”
Consumer demand for cleaning and disinfecting products continues to soar.
“The Pope couldn’t have bought a bottle of Lysol last week if he wanted to, and now because of the EPA’s approval [of Lysol] it’ll be even harder,” said Josh Bloom, director of chemical and pharmaceutical sciences at consumer advocacy group American Council of Science and Health (ACSH).
Over the past five months, the EPA has approved nearly 750 products that license formulations as potentially effective against COVID, according to a list compiled by the American Chemistry Council trade group.
In late February, the list had only about 100 products, almost all from Lysol and Clorox. By June, the ACC list was comprised mostly of other brands licensing formulations from primary registrants Lonza, Pilot and Stepan, according to a Reuters analysis.
Stepan and Pilot were not immediately available to comment.

How immune system T cells fight coronavirus in absence of antibodies

As scientists question whether the presence, or absence, of antibodies to the novel coronavirus can reliably determine immunity, some are looking to a different component of the immune system, known as T cells, for their role in protecting people in the pandemic.
Recent studies show that some recovered patients who tested negative for coronavirus antibodies did develop T cells in response to their COVID-19 infection. While the studies are small and have yet to be reviewed by outside experts, some scientists now say that people who experience a mild illness, or no symptoms at all, from the new coronavirus, may be eliminating the infection through this T cell response.
The findings add to the evidence that an effective COVID-19 vaccine will need to prompt T cells to work in addition to producing antibodies, and may have implications for several treatments in development. They may also shed light on how immunity to new exposure to infection could work.
“There is mounting evidence that people exposed to the virus have a transient (short-lived) antibody response, or have a T cell response in spite of a minor or absent antibody response,” Dr Alessandro Sette, professor and member of the La Jolla Institute’s Infectious Disease and Vaccine Center in California, told Reuters.
When a virus gets past the body’s initial defenses – which include infection-fighting white blood cells – a more specific “adaptive” response kicks in, triggering production of cells that target the invader. These include antibodies that can recognize a virus and lock onto it, preventing its entry into a person’s cells, as well as T cells that can kill both invaders and the cells they have infected.
Six months into a global COVID-19 pandemic that has infected more than 12 million people, questions remain about whether the antibody response to this virus is robust and lasts over time. That could mean T cells have a more important role in offering protection against the illness.
“T cells are often important in controlling viral infections. We are seeing evidence of that,” John Wherry, director of the University of Pennsylvania’s Institute for Immunology, told Reuters.
A recent small French study here not yet reviewed by experts, found that six out of eight family members in close contact with relatives who had COVID-19 developed a T cell response, but did not test positive for antibodies.
A Swedish study here of 200 people found a strong T cell response in most individuals who had mild illness or no symptoms following coronavirus infection, regardless of whether they showed an antibody response. The finding suggests that coronavirus infection rates may be higher than what has been studied using antibody tests alone, the researchers said.

MEMORIES OF CORONAVIRUS

The focus on T cell responses could also shed light on the prospect for longer-term immunity.

There is some evidence that T cells developed after exposure to other coronaviruses that cause the common cold could help fight off the new virus, known as SARS-CoV-2.
A study led by the La Jolla Institute detected T cells that reacted to SARS-CoV-2 in about half of stored blood samples collected between 2015 and 2018, suggesting that the immune system cells developed after previous infection with circulating common cold coronaviruses, and that they might help protect against the new virus.
“It is a potentially encouraging piece of evidence,” Wherry said.
Vaccine candidates against COVID-19 currently in the works aim to generate antibody and T cell responses, and the recent findings highlight the importance of gauging the T cell response seen in human clinical trials.
“We believe that the optimal vaccine design would be one that induces both an antibody and T cell response,” Sette said.
After an infection or vaccination, the immune system retains a number of “memory” cells that are already primed to quickly attack the same virus in case of a future infection.
Many countries are using blood tests that look for antibodies to estimate how many people have been infected with the new virus even if they never showed symptoms. But scientists still do not know how antibody levels correlate to exposure to the virus or how long they may last. There are also questions about exactly which combination of immune-system cells will result in significant protection.
Measuring the level of memory T cells is much more complicated, especially if the cells are in lymph nodes or other hard-to-access areas of the body. In addition, T-cell responses are highly variable.
“It is a lot easier to collect antibody data,” said Dr Daniela Weiskopf, an assistant professor at the La Jolla Institute.

FDA to resume on-site inspections in U.S.

The FDA intents to restart on-site inspections in the U.S., shut down in March due to the COVID-19 pandemic, the week of July 20.
Inspections will be prioritized according to a rating system based on real-time state and national data to assess the number of COVID-19 cases in a given area. The system will generate an “advisory level” based on the outcome of three metrics: phase of the particular state and county-level statistics on the current trend and intensity of infections.
County-level “advisories” will be parsed as: mission-critical inspections only, all inspections with caveats to help protect staff and resumption of all regulatory activities.
Inspections will be pre-announced to ensure the safety of all concerned with the exception of retail tobacco sites since they are undercover operations.
The agency says it will need to see a downward trend in new cases before upgrading an area to a less-stringent level.

Biotech IPO Nkarta triples in debut

Nkarta (NASDAQ:NKTX) had a big IPO, upsizing the number of shares sold to 14M from 10M. It also priced at $18 vs. the expected range of $16-$17. The offering raised $252M.
That was just a preview though, as insiders may have left a little bit of money on the table. The stock opened for trade at a whopping $54.75, more than triple the IPO price. It climbed as high as $58, and is currently changing hands at $50.81.
All of the company’s drugs (for treatment of acute myeloid leukemia and myelodysplastic syndrome) are in preclinical stage.
Major competitors: Fate Therapeutics (NASDAQ:FATE), CRISPR Therapeutics (NASDAQ:CRSP), Allogene (NASDAQ:ALLO), Cellectis (NASDAQ:CLLS), Celyad (NASDAQ:CYAD), Takeda Pharmaceutical (NYSE:TAK).

Thermo Fisher bid for Qiagen inadequate – investor

QIAGEN N.V. (QGEN +1.3%) is up modestly, albeit on below-average volume, on the heels of a letter to its board from institutional investor Davidson Kempner stating that Thermo Fisher Scientifics’ (TMO -1.1%) €39/share bid (€10.4B) is “inadequate” and “fails to reflect” [the company’s] fundamental standalone value and offers shareholders “no premium for control.”
Davidson Kempner owns 3% of the diagnostic test maker.
In June, United First Partners’ Stephane Mardel said that TMO may have to boost its offer after proxy advisor Glass Lewis recommended voting against “Top Up” resolutions.

Hologic coronavirus test shows 100% sensitivity in study

Hologic (HOLX +0.1%) is up modestly on below-average volume on the heels of the publication of performance characteristics of its SARS-CoV-2 molecular test performed on its automated Panther system.
The test showed concordance of 100% in sensitivity and 98.7% in specificity with validated PCR results for SARS-CoV-2 RNA.
The test’s analytical sensitivity was 100% using three commercially available SARS-CoV-2 nucleic acid controls with no cross-reactivity or interference with six related human coronaviruses as well as 24 other viral, fungal and bacterial antigens, all at high titer.
The FDA signed off on emergency use of the assay for COVID-19 in May.