Russia plans COVID-19 vaccine output at 6 million doses a month

Russia expects to produce between 1.5 million and 2 million doses per month of its potential COVID-19 vaccine by the year end, gradually ramping up production to 6 million doses a month, the RIA news agency cited industry minister Denis Manturov as saying on Sunday.

Large-scale testing of the vaccine, developed by Moscow’s Gamaleya institute, is due to start in Russia next week.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/russia-plans-covid-19-vaccine-output-at-6-million-doses-a-month-ria-idUSKBN25J0BM

UK health advisers say missing school greater risk than Covid to kids

The chief medical officers of the United Kingdom have said children should return to school after the summer holidays, warning that missing out on their education posed much bigger risks to them than catching COVID-19.

The rare joint statement from the top health advisers to the governments of England, Scotland, Wales and Northern Ireland represents a boost for British Prime Minister Boris Johnson who has said getting children back to school is a national priority.

Confidence in the government’s approach to schooling during the coronavirus pandemic took a hit last week when education minister Gavin Williamson was forced into an embarrassing U-turn over examination results.

“Very few, if any, children or teenagers will come to long term harm from COVID-19 due solely to attending school,” they said. “This has to be set against a certainty of long-term harm to many children and young people from not attending school,” the CMOs said in a joint statement published late on Saturday.

Evidence showed that a lack of schooling increased inequalities, reduced opportunities and could exacerbate physical and mental health issues, the statement said.

By contrast there was clear evidence of a very low rate of severe disease in children, even if they caught COVID-19, and an exceptionally low risk of dying.

“The percentage of symptomatic cases requiring hospitalisation is estimated to be 0.1% for children aged 0-9 and 0.3% among those aged 10-19, compared to a hospitalisation rate of over 4% in the UK for the general population,” the statement said.

Johnson has said reopening schools in September is a social, economic and moral imperative, insisting they would be able to operate safely despite the COVID-19 pandemic.

Separately, England’s chief medical officer was quoted as saying it would be foolish to count on a coronavirus vaccine being ready for use this year.

“I think if we look forward a year, I think the chances are much greater than if we look forward six months and we need to have that sort of timescale in mind,” Chris Whitty told Sky News.

“So planning for the next winter, it would be foolish to plan on the basis we will have a vaccine.”

https://www.reuters.com/article/us-health-coronavirus-britain/uk-government-health-advisers-say-missing-school-is-greater-risk-to-kids-than-covid-idUSKBN25J08J

Antibody Drugs Advancing to Fill Covid-19 Treatment Gap

A kind of drug that takes a page from a body’s natural antibody defenses may be able to give many people early protection against the coronavirus, ahead of vaccines.

Few treatments so far have been shown to be effective against Covid-19, and even then, only in hospitalized patients. Potential vaccines, meanwhile, are probably months away from completing testing and becoming available to the general public.

Researchers and health officials express hope certain drugs, known as monoclonal antibodies and in testing by companies including Regeneron Pharmaceuticals Inc. and Eli Lilly & Co., will fill the breach.

“There is a need for safe therapies to be given early in disease and monoclonal antibodies are paramount among them,” said National Institute of Allergy and Infectious Diseases Director Anthony Fauci. “I’m very anxious to see what the results are.”

The drugs, which are injected intravenously or with a short needle, have the potential to work soon after someone is infected and still feeling only slightly sick, stopping the virus in its tracks before the seriously afflicted would need to be hospitalized.

The monoclonal antibodies might also prevent infection in healthy people, though likely only for about a month. If the promise bears out during testing, the drugs could stand in as a type of temporary vaccine for people at high risk of infection, such as nursing-home residents and possibly health-care workers.

Today if you get Covid, you will have a wave of fear of biblical proportions,” said Myron Cohen, an infectious-disease specialist at the University of North Carolina who is overseeing antibody studies for the NIAID.

“If I can give you a shot and guarantee you I stop the progression of disease, the world changes,” he added.

Among the companies planning to launch antibody studies in people this year are Vir Biotechnology Inc. and partner GlaxoSmithKline PLC, and privately held Adagio Therapeutics Inc. AstraZeneca PLC this month launched a Phase 1 study of an antibody drug it licensed from Vanderbilt University.

Covid-19 clinical trials are now under way for 10 new monoclonal antibodies, known as mAbs in industry jargon, according to the Antibody Society, a professional association of researchers.

The most advanced are already in mid- and late-stage studies in newly diagnosed as well as hospitalized patients, and in people who haven’t yet been infected. If they clear testing, the drugs might be available as soon as early in the fourth quarter, according to Geoffrey Porges, an SVB Leerink LLC analyst.

Early signs are preliminary but positive. Regeneron’s antibody drug both cleared and prevented coronavirus infections in a study in monkeys and hamsters.

Another reason for optimism, infectious disease experts say, is that the antibody drugs developed by Regeneron and the National Institutes of Health were shown to be effective in the Ebola virus.

Yet some researchers who expect antibody drugs to work in clinical trials are skeptical how much real-world impact they would then have.

Doctors may be reluctant to prescribe a brand-new, expensive medication to patients early on in their disease when the drug is most likely to be effective, said Florian Krammer, a microbiologist at the Icahn School of Medicine at Mount Sinai in New York.

“The problem is putting it into practice and when are you going to use them?” said Dr. Krammer. “Are you going to give it to someone who comes in who’s only a little symptomatic? Probably not.”

The drugs would likely be used preventively by those at high risk of infection or severe complications from the disease, such as nursing-home residents and workers, or people exposed to a household member who tested positive for the virus.

Regeneron and Eli Lilly say that even if the drugs work, there won’t be enough to treat everyone because there aren’t enough manufacturing plants able to do the high-tech manufacturing that mAbs require.

Finite supplies will mean that government officials, nonprofit organizations and drugmakers will likely have to come together to set guidelines for who gets the drugs, said Eli Lilly Chief Scientific Officer Dan Skovronsky.

“It’s not a question of cost or working harder or a desire to make it. It’s just the simple math, the number of manufacturing facilities in the world that are available,” he said. “And we can’t stop making cancer drugs or insulin or anything like that.”

Regeneron joined with rival Roche Holding AG this past week to more than triple the manufacturing capacity for its drug, but said the increase probably still won’t be enough to meet demand.

Monoclonal antibodies are human-made cells that latch onto proteins that drive disease.

Their discovery in the 1970s helped give birth to the modern biotechnology industry, and they have been turned into blockbuster treatments for cancer, vision loss and chronic inflammatory diseases.

Doctors and health officials are looking to the drugs to fill a big gap in Covid-19 treatment. The only drugs shown to be effective against the disease are for sick patients well along the course of the disease, not for patients in the early stages of infection.

Vaccines promise to protect people against infection, or at least reduce the severity of a case. The most advanced are just starting late-stage testing. And if they pass muster, there probably won’t be enough initial supplies for many people.

Regeneron and Lilly executives say the complexities of conducting studies during the pandemic make it difficult to confidently predict when they will have firm answers on which patients respond best to their drugs, if at all.

To quickly enroll patients, the companies have had to predict virus hot spots ahead of time and then work with overworked doctors who may be too overwhelmed to always focus on clinical trials.

“We’re a little bit like storm chasers, but we’re pandemic chasers,” said Regeneron Chief Executive Leonard Schleifer.

Delays getting coronavirus test results for potential study subjects are also complicating enrollment. The delays, of as much as 10 days, wind up disqualifying some patients from studies that require them to be enrolled within three or four days of testing positive.

“If you can’t test people rapidly, that precludes being able to do a study in recently diagnosed people,” said Lilly’s Dr. Skovronsky. “Improved diagnostics is part of the answer to improved therapeutics.”

In August, late-stage studies were launched evaluating Lilly’s lead antibody in hospitalized and nonhospitalized patients, and these could be completed before the end of the year, depending on how quickly patients are enrolled.

Regeneron expects to have the first data from its study of a monoclonal antibody in hospitalized and nonhospitalized patients by the end of September. The company could seek an emergency authorization based on the data if there is a strong indication the drug is blocking the virus.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Antibody-Drugs-Advancing-to-Fill-Covid-19-Treatment-Gap-31163485/?countview=0

President sets Sunday news conference on ‘major Covid therapeutic breakthrough’

White House Press Secretary Kayleigh McEnany announces a presidential news conference to take place at 6 PM ET on Sunday “concerning a major therapeutic breakthrough on the China Virus.”

Attending alongside the president will be HHS Secretary Alex Azar and FDA chief Stephen Hahn.

https://seekingalpha.com/news/3608031-president-sets-sunday-evening-news-conference-on-major-therapeutic-breakthrough-for

Pointless Quarantine

At the end of March, Rhode Island governor Gina Raimondo issued an executive order directing police to pull over cars with New York plates at the state border and order them to quarantine for 14 days or face fines and possible jail time. New Yorkers were outraged. New York governor Andrew Cuomo claimed Rhode Island was motivated by fear and opined, “I don’t think the order was called for, I don’t think it was legal, I don’t think it was neighborly.” He threatened legal action. Rhode Island replaced the order with a new one mandating that all travelers with out-of-state plates undergo a 14-day self-quarantine.

Now, Governor Cuomo is doing exactly what he condemned a few months ago. Pursuant to his Executive Order 205, New York has created a list of more than 30 “restricted” states from which travelers must quarantine for 14 days if they enter the Empire State. Violators may be subject to a fine of up to $10,000. These restrictions make little sense, are overbroad, and penalize rather than protect New Yorkers. And they are, as a practical matter, unenforceable.

The resulting New York travel advisory—jointly issued with neighboring states of New Jersey and Connecticut—targets states with ten or more positive Covid tests per 100,000 population, an absurdly low starting point. That means a random traveler from such a state has only a one in 10,000 chance (0.01 percent) of being positive. But a sick person is less likely to be traveling than an asymptomatic person. Since half or more of Covid-19 patients are symptomatic, we could cut these odds by half.

The advisory also targets states where 10 percent or more of tests are positive over a seven-day rolling average. But this statistic alone is largely meaningless. It is dependent on the number of tests being performed and why they are performed. If testing is performed only on symptomatic people, or people who have reason to believe they have been exposed or are infected, the positivity rate will be higher. If testing is more general and widespread, the rate will be lower. The data point may indicate high infection rates in the community; more likely, it represents insufficient testing.

The advisory does not apply to individuals who spend less than 24 hours in a designated state during their travels—an arbitrary standard. There is nothing magical about a 24-hour period. A traveler to a state with rampant Covid-19 transmission can go to the gym, get a manicure, and top off their evening in a restaurant but be excused as long as they complete their activities and leave the state in under 24 hours. Meantime, someone who spends two days in a remote cabin in Montana must quarantine.

The advisory also includes a lengthy and onerous list of requirements for self-quarantine and provides a phone number and email address for people to report those who do not adhere to the requirements. There is little that the state can do to enforce the quarantine requirements, which all but ensures that they will be ignored. And encouraging busybodies to turn in their neighbors is sure to increase social strife at a time when we can least afford it.

Worst of all, the advisory’s focus on states is overbroad. Covid-19 outbreaks have been highly concentrated in particular counties, rather than in entire states. In New York, once the nation’s epicenter, nearly all the cases have been in and around New York City. The five counties that make up the city have a cumulative rate of 27.5 cases per 1,000 population. Just north of the city, Westchester county is even higher, at 37.7 per 1,000. Yet since the start of the pandemic, most other counties in New York State have registered much lower rates, remaining under five cases for every 1,000 residents.

The situation is the same in current hotspots. Los Angeles accounts for 10 percent of California’s population but 37 percent of its Covid-19 cases. Miami-Dade County is about 13 percent of Florida’s population but has 25 percent of its Covid-19 cases. Shouldn’t New York distinguish between Texas travelers from Dallas County (22 cases/1,000) and Collin County (9.7 cases/1,000) just to the north—or from Cameron County (42.1 cases/1,000) on the southern border?

New York currently has 33 states plus Puerto Rico and the Virgin Islands on its list—virtually every state outside of the northeast. That means that New Yorkers who don’t want to add two weeks of quarantine onto the end of their travels are essentially barred from most of the country. The advisory also penalizes economic activity in New York, since no tourist or business person will travel to the state if they have to quarantine for two weeks.

Governor Cuomo is about to publish a book on his pandemic experience. One hopes that he has learned that ill-advised, poorly executed policies have real consequences. New York’s travel restriction is poorly designed and counterproductive. Rather than providing any real protection, it will simply punish New Yorkers and impede the state’s economic recovery. It’s time to revamp or revoke it.

Joel Zinberg, M.D., J.D., is a senior fellow at the Competitive Enterprise Institute in Washington D.C. and professor of surgery at the Mount Sinai Ichan School of Medicine in New York. He was general counsel and senior economist at the Council of Economic Advisers (2017-2019), where he specialized in health policy.

https://www.city-journal.org/new-yorks-pointless-travel-restrictions

Virginia Plans Mandatory COVID-19 Vaccinations For All Residents

As Friday’s hospitalization numbers across the Sun Belt appear to confirm CDC head Dr. Robert Redfield’s assertion that the American COVID-19 outbreak has peaked and is starting to fade, the State of Virginia is setting a new precedent by seriously discussing forcing Virginians to be vaccinated with whatever rushed-to-marked candidate the FDA approves first.

During an interview that aired on Friday, the state’s health commissioner said he planned to invoke state law to make vaccinations mandatory – once a western product is available, presumably.

Here’s more from ABC News 8:

State Health Commissioner Dr. Norman Oliver told 8News on Friday that he plans to mandate coronavirus vaccinations for Virginians once one is made available to the public.

Virginia state law gives the Commissioner of Health the authority to mandate immediate immunizations during a public health crisis if a vaccine is available. Health officials say an immunization could be released as early as 2021.

Dr. Oliver says that, as long as he is still the Health Commissioner, he intends to mandate the coronavirus vaccine.

“It is killing people now, we don’t have a treatment for it and if we develop a vaccine that can prevent it from spreading in the community we will save hundreds and hundreds of lives,” Oliver said.

Pro-medical-choice activists in the state argue that the issue is a matter of medical choice, and that the hasty “expedited” approval process being implemented by the FDA is grounds for concern. State health authorities insist, meanwhile, that they would never mandate a vaccine that hadn’t already proven to be safe.

Virginia Freedom Keepers Director of Communications Kathleen Medaries, a mother of three from Chesterfield, says this is a matter of medical choice.This is not a Republican or Democrat issue. It’s not a pro-vaccine or anti-vaccine issue,” Medaries said. “For me, it’s an issue of being able to assess each vaccine for myself and my family one at a time.”

[…]

“He shouldn’t be the one person to make a decision for all of Virginians,””Medaries responded.

The state’s top medical official is opposed to a bill that has been put forth in the state assembly that would create more exemptions to the mandatory vaccination power, allowing exemptions on religious and other grounds.

Oliver believes that COVID-19 is a public health emergency that should take precedent over everything else, and that vaccine-assisted herd immunity is the state’s best and only real defense.

The decision comes after Massachusetts said it would make the flu vaccine mandatory this year as part of a campaign to protect the state’s medical system. We suspect Virginia and Massachusetts won’t be the only states to discuss mandatory COVID and/or flu vaccination in the coming weeks, as the school year begins.

https://www.zerohedge.com/geopolitical/virginia-plans-mandatory-covid-19-vaccinations-all-residents

Ex-FDA Commissioner Gottlieb Analyzes J&J Mega Vaccine Trial

Johnson & Johnson JNJ 0.86% plans on enrolling up to 60,000 people in a coronavirus vaccine trial, likely as part of a global development and regulatory approval strategy, ex-FDA Commissioner Scott Gottlieb said Friday on CNBC’s “Squawk Box.”

J&J’s Global Approval Strategy: J&J could enroll up to 60,000 people worldwide as part of a vaccine trial at a time when other vaccine makers are recruiting roughly half that number, Gottlieb said.

J&J will likely look to oversee large trials in many regions at the same time to make it easier to file for regulatory approval, he said. 

In order to gain regulatory approval from foreign agencies, a vaccine maker needs to conduct studies in that specific region, Gottlieb said.

COVID-19 Timeline Update: Vaccine makers like Pfizer Inc. PFE 0.39% are recruiting 30,000 people in the U.S., the ex-FDA commissioner said.

Even at half the size of J&J’s study, Pfizer’s vaccine study is still very robust, he said.

If successful, the U.S. government could give the vaccine an emergency authorization use for a select population group that is at high-risk, Gottlieb said, adding that the vaccine maker would still need to collect information at that point. 

A few vaccine makers have made recent announcements that they are seeing success in the enrollment phase.

Moderna Inc MRNA 2.01% and AstraZeneca plc AZN 1.4% each said they have already enrolled 8,000 people in the U.S.

“These trials seem to be enrolling pretty well,” Gottlieb said. 

https://www.benzinga.com/general/health-care/20/08/17189562/ex-fda-commissioner-analyzes-johnson-johnsons-mega-vaccine-trial