Gargling Could Slow Covid-19 Spread, Mouthwash Makers Say

 Wash your hands, wear a mask and don't forget to gargle with mouthwash.

That's the message Unilever PLC and Colgate-Palmolive Co. are carefully starting to push after research they commissioned showed that certain types of mouthwash and toothpaste could potentially help deactivate the virus that causes Covid-19.

Now, Unilever is launching mouthwash brands in new markets, while Colgate has shared the results of its study with dentists.

Reducing virus particles in the mouth could help fight against the pandemic, the companies said, because Covid-19 can be spread through droplets generated when an infected person coughs, sneezes or speaks. Both companies said the mouthwashes dissolve the outer protective layer of virus particles, preventing them from attaching to cells and infecting them.

But based on tests so far they can't definitively say how long the benefit would last or what impact coughing would have. That makes it hard to judge how useful oral-hygiene products could be in curbing transmission.

Unilever said an October lab-based study it commissioned found mouthwash containing cetylpyridinium chloride, or CPC -- an ingredient used by dentists for its antibacterial properties -- reduced SARS-CoV-2 particles by 99.9% after 30 seconds of rinsing.

"While we are clear that this is not a cure or proven way to prevent the transmission of coronavirus, the results are very promising," said Glyn Roberts, Unilever's head of research and development for oral care.

Early in the pandemic, scientists from Cardiff University in Wales and other institutions called for more research into the potential role of mouthwash in fighting Covid-19. Previous studies, they said, had shown that ingredients commonly found in mouthwashes could deactivate other viruses. Mouthwash makers say sales have risen this year amid broader demand for hygiene products.

Angela Rasmussen, an associate research scientist at Columbia University's Center of Infection and Immunity who reviewed the results of the study commissioned by Unilever, said that the findings were promising but results from human trials are needed.

"What happens in a culture dish is not indicative of what would happen in a patient's actual mouth and throat," said Ms. Rasmussen. "While it's great for a short period of time to reduce virus secreted by those cells, what really is going to be important is how long that effect will last."

Unilever said it plans to follow its study -- in which scientists from Microbac Laboratories used a culture dish to simulate the viral load in the mouth -- with a trial in at least 50 people early next year. It will also look into how mouthwashes could impact other viruses.

In the meantime, Unilever is launching mouthwash with CPC in a string of new markets, from Italy and France to India and Indonesia, under brands including Pepsodent, Mentadent, Signal and Close-Up. The company doesn't plan to launch these in the U.S., where its oral-care business is smaller and the regional rights to some of the brands are held by other companies.

Unilever isn't making any new claims on product packaging, but has been promoting its findings through social media and its website.

Colgate, the world's largest toothpaste maker, said its lab tests, conducted by Rutgers New Jersey Medical School, also showed some kinds of toothpaste, mouthwash and mouth spray can virtually eliminate the virus that causes Covid-19. The toothpastes contain zinc or stannous, a mineral that can help fight gum disease, while the mouthwashes contain CPC.

Colgate said it is sharing its findings with dentists and notes many are now asking patients to rinse before procedures to reduce the possible presence of the virus.

The company said a separate clinical trial testing mouthwash on 50 hospitalized people suggested the benefit could last between 30 and 60 minutes after rinsing. Full results haven't yet been shared.

The company is also funding additional clinical studies in the U.S. and Brazil in which 260 people with Covid-19 are participating.

"We think oral care has a role to play in fighting the global pandemic, alongside other preventive measures," said Colgate's Chief Clinical Officer Maria Ryan.

Some companies say it is too early to make any virus-related claims about mouthwash or toothpaste.

Johnson & Johnson, owner of Listerine, said lab-based findings about oral-care products and the virus, while high quality, aren't sufficient to advocate the use of mouthwash as a prevention measure.

"Listerine Antiseptic is not intended to prevent or treat Covid-19 and should be used only as directed on the product label," a spokeswoman said, adding that J&J intends to actively participate in the scientific exchange on this topic.

In October, J&J said its third-quarter oral-care sales grew 10.8%, partly attributing the rise to "increased demand globally related to the Covid-19."

Procter & Gamble Co. isn't commissioning its own studies and said it is too early to tell how mouthwashes impact the virus. It said its Crest mouthwashes, many of which contain CPC, are being tested by third parties.

https://www.marketscreener.com/quote/stock/THE-PROCTER-GAMBLE-COMP-4838/news/Gargling-Could-Slow-Covid-19-Spread-Mouthwash-Makers-Say-31999922/

Trump: first shot of Pfizer vaccine in U.S. will be given in less than 24 hours

 President Donald Trump said late on Friday after the U.S. Food and Drug Administration approved Pfizer Inc’s COVID-19 vaccine that the first shot would be administered in the United States in less than 24 hours.

https://www.reuters.com/article/us-health-coronavirus-usa-trump/trump-first-shot-of-pfizer-vaccine-in-u-s-will-be-given-in-less-than-24-hours-idUSKBN28M045

Mexico approves emergency use of Pfizer's COVID-19 vaccine

 Mexico has become the fourth country to approve emergency use of Pfizer’s COVID-19 vaccine, following authorization from health regulator Cofepris, a health official said on Friday.

“Cofepris has granted emergency authorization to the Pfizer and BioNTech vaccine,” deputy health minister Hugo Lopez-Gatell told a news conference, referring to Pfizer’s German partner. “This is cause... for hope.”

Britain, Bahrain and Canada have already approved the Pfizer vaccine. The U.S. Food and Drug Administration on Friday was on the cusp of authorizing its emergency use.

Cofepris said in a statement that it granted authorization to Pfizer after the 24 members of its advisory committee voted unanimously in favor.

Mexico’s government has already inked an agreement with Pfizer to acquire 34.4 million doses of its vaccine, with the first batch expected to arrive this month.

Mexico on Friday registered 12,253 new confirmed cases of coronavirus infection and 693 additional fatalities, bringing the total in the country to 1,229,379 cases and 113,019 deaths.

https://www.reuters.com/article/us-health-coronavirus-mexico/mexico-approves-emergency-use-of-pfizers-covid-19-vaccine-idUSKBN28M019

With U.S. now in hand, BioNTech CEO looks for more vaccine production

 The chief executive of Germany’s BioNTech SE said the biggest challenge facing it and partner Pfizer Inc now that their COVID-19 vaccine is authorized for use in the United States will be to scale up manufacturing to meet huge demand.

“We need to solve the manufacturing challenge,” Ugur Sahin told Reuters in an interview. “It is very clear that more doses are needed. And we are dealing with that question - how to produce more doses.”

The companies have said they will produce up to 1.3 billion doses of the vaccine next year.

The U.S. Food and Drug Administration authorized the vaccine for emergency use on Friday, after Britain became the first country to begin deploying the shot outside of clinical trials earlier in the week.

Sahin said he expects the companies will receive conditional approval from the European Medicines Agency by the end of the month and can begin rolling out vaccine in European countries early next year.

One way he hopes to boost supply would be by bringing on earlier than projected the 750 million-dose-a-year plant BioNTech bought from Novartis AG in Marburg, Germany.

BioNTech had said it would begin making the vaccine there in the first half of 2021, and Sahin said they are working to get it up and running on an expedited timeline.

“The baseline plan is 1.3 billion doses,” Sahin said. “And we are working on an extended plan. I can’t tell you at the moment what is possible and how much we can expand the scale but we will try to do it significantly.”

Supply of the vaccine will be limited at first in the United States, which has a population of roughly 330 million. The U.S. government has ordered 100 million doses of the two-dose vaccine and could negotiate for more.

Pfizer board member and former FDA commissioner Scott Gottlieb said in an interview with CNBC the company had offered to sell the United States more doses as recently as last month but had been turned down.

In data released this week, Pfizer and BioNTech said their vaccine began conferring some protection to recipients even before they received the second shot. It seemed to begin to show some efficacy around 12 days after the first shot.

Sahin said he was surprised by the data: “We know that the immune response is heavily boosted after the second dose.”

He said the companies have not decided yet whether to evaluate a single-dose version of the vaccine.

“This will be a discussion that we will certainly have with our partners Pfizer,” he said.

https://www.reuters.com/article/us-health-coronavirus-vaccines-biontech/with-u-s-now-in-hand-biontech-ceo-looks-for-more-vaccine-production-idUSKBN28M064

CVS to begin Covid-19 vaccinations on December 21

 

• CVS Health (CVS) has set December 21 to kick off its COVID-19 vaccine program with the administration of the shots to the residents of long-term care facilities, according to Reuters.
• Yesterday, a panel of experts endorsed the COVID-19 vaccine candidate from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) potentially paving the way for an impending FDA emergency use authorization.
• Though the company expects to receive the shipments of the next week, the vaccination will take a few days to start in order to give nursing home administrators time to get waivers from nursing home residents and families for the shot.
• A week later, the program will add the vaccine candidate from Moderna (NASDAQ:MRNA), scheduled for a similar review by the advisory panel next week.
• The company has an agreement with the federal government to vaccinate nursing home residents across the country through a voluntary program.
• https://seekingalpha.com/news/3643753-cvs-to-begin-covidminus-19-vaccinations-on-december-21

FDA grants historic authorization to a Covid-19 vaccine

 

The Food and Drug Administration on Friday issued an emergency authorization for a Covid-19 vaccine developed by Pfizer and its German partner, BioNTech, a seminal moment in the effort to curb a pandemic that has so far infected an estimated 16 million people and killed nearly 300,000 in the United States.

The decision means vaccinations will begin in a matter of days in individuals age 16 years of age or older. Initial supplies of the vaccine are expected to be used primarily in two groups most at risk of getting infected or developing severe disease: health care providers and residents and staff of long-term care facilities.

The vaccine is the first to be authorized in the United States, and has already been authorized in the United Kingdom, Canada, and several other countries. But neither in those countries, nor in the United States, is the vaccine expected to be a panacea for the pandemic. 

While the vaccine was shown to reduce the risk of developing symptomatic Covid-19 infection by about 95% in Phase 3 clinical trials, a number of factors may constrain its potential to turn the pandemic’s tide, at least in the short term. Among other issues: Initial supplies of the vaccine are extremely limited; many Americans are reluctant to take the vaccine at all; and in certain populations, including people who are pregnant and children, the vaccine has not yet been tested.

Importantly, while the vaccine reduces the risk of developing symptomatic infection, it’s not yet clear whether it also reduces transmission of the virus that causes the disease, SARS-CoV-2. It’s possible that people who are vaccinated can still contract the virus and then transmit it to others, though they themselves would not get sick. As a result, health officials are urging everyone, including the vaccinated, to continue to practice social distancing measures and to wear masks.

The Pfizer/BioNTech vaccine was developed at breakneck speed, and the Trump administration agreed over the summer to an initial $1.95 billion purchase of 100 million doses, before knowing whether it would be safe and effective.

In clinical trials, it proved to be both. The most common side effects included pain at the injection site, fatigue, and fever. Serious adverse reactions were rare. In a 44,000-volunteer study, there were four cases of Bell’s palsy, a temporary weakness or paralysis, in the vaccine arm and none in the placebo arm. There were also 64 cases of lymphadenopathy, a swelling of the lymph nodes, in the vaccine group versus six in the placebo group. Those cases all resolved.

The FDA’s decision follows the recommendation of an advisory committee that an emergency use authorization be granted to the vaccine. The same committee is scheduled to meet on Dec. 17 to review data on a vaccine developed by Moderna, a biotechnology company based in Massachusetts. Its vaccine had efficacy levels similar to Pfizer’s and is based on the same technology, known as messenger RNA. It is widely expected to be authorized.

Operation Warp Speed, the U.S. effort to fast-track development of Covid-19 vaccines, currently estimates it will have enough vaccine for 20 million people by the end of December between the Pfizer and Moderna vaccines.

A number of other vaccine candidates are still in clinical trials.

The rollout of any vaccine is expected to be complex, and there remain concerns about vaccine makers’ ability to scale up manufacturing to meet demand, not just in the United States but globally. Still, the development and distribution of a vaccine less than a year after the emergence of an unknown pathogen is widely considered a feat once thought impossible.

https://www.statnews.com/2020/12/11/fda-grants-historic-authorization-to-a-covid-19-vaccine-setting-stage-for-rollout/

If you already had COVID, do you need the vaccine?

 More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. regulators.

Short answer: Yes.

"They will be asked to stand in line and get a vaccine also," said Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center in Nashville, Tenn. "There will be no distinction made, in part because we think there's no adverse event that will occur, and also the protection from the vaccine actually may be more long-lived, of longer duration than that you get from the natural infection."

Coronaviruses are notorious for prompting a flawed and incomplete immune response in humans, infectious disease experts say.

It's one reason why science has yet to come up with a cure for the common cold.

"With the four seasonal beta coronaviruses that circulate and cause all the upper respiratory infections you see in your practice, those people lose immunity in months to a year or two," said Dr. Gregory Poland, director of the Vaccine Research Group at the Mayo Clinic in Rochester, Minn. "That's why people fall prey to the common cold again and again."

The body uses a relatively simple strategy to fight off common cold coronaviruses, and this strategy does not appear to make a lasting impression on immune system memory, Poland said.

There's a chance that people who have had asymptomatic or mild cases of COVID-19 did not build up any lasting immunity. In fact, it's even unclear at this point what sort of immunity is conferred by severe or life-threatening cases.

"While natural infection does provide protection for some period of time, it is somewhat unpredictable how robust that response is in individuals," said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security, in Baltimore.

A recent COVID-19 infection could put a person a bit farther back in line for the vaccine, however.

"It is true that those who had a recent infection—within 90 days—should be behind those who hadn't," Adalja said, noting recommendations from the Vaccine Advisory Committee for the U.S. Centers for Disease Control and Prevention.

More threatening coronavirus diseases like SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) appear to produce immunity that lasts longer, but the data is limited because both viruses have infected far fewer people than the COVID-19 pathogen, experts said.

COVID-19 patients shouldn't feel as though they're getting nothing from the vaccine, Adalja added.

"In those that have recovered, the vaccine will boost natural immunity and it will be more effective at preventing disease," he said.

The clinical trials for both the Pfizer-BioNTech and Moderna vaccines are expected to provide more insight into their benefit for previously infected patients as participants continue to be monitored over coming months and years, Adalja said. The trials included some people who had already been infected.

"This is an active area of study and the vaccine trials will be analyzed in detail to see how the vaccine impacted natural immunity, as 10% of those in the trials had prior infection," Adalja said.

https://medicalxpress.com/news/2020-12-covid-vaccine-2.html