November 18 coronavirus news

The US Food and Drug Administration (FDA) has issued an emergency use authorization for the first self-test for Covid-19 that can provide rapid results at home.

The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test available by prescription for self-diagnosis of the coronavirus, the agency said Tuesday.

It uses a molecular amplification technology to search for signs of the coronavirus’s genetic material.

How does it work? The kit includes a sterile swab, a sample vial, a test unit, batteries and a plastic disposal bag.

A user first needs to self-collect a nasal swab sample and insert it into the vial, which then enters the test unit where it is analyzed. The results are displayed on the test unit by a color change in the LED indicators, according to the FDA.

Who can use it? The new test is authorized for people aged 14 and older with suspected Covid-19 and people under 13 when performed by a health care provider.

It is also authorized for use in point-of-care settings, such as doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages but must be collected by a health care provider, the FDA said.

The state of Washington reported 2,677 new coronavirus cases Tuesday, a new single-day high, according to its health department.

Following the release of the latest numbers, Gov. Jay Inslee said on Twitter: “We need everyone doing their part to stop this virus.”

Washington has recorded a total of 131,444 Covid-19 cases and 2,571 deaths. Currently, 9,573 patients are hospitalized.

Note: These numbers were released by the Washington state Department of Health and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project.

Rep. Ed Perlmutter, a Democrat from Colorado, announced Tuesday night that he has tested positive for Covid-19. 

Perlmutter was on Capitol Hill during a series of votes Monday. 

This brings the number of House members and senators who have tested positive for the coronavirus to 33.

Republican Sen. Chuck Grassley of Iowa also announced Wednesday that he had tested positive.

The Australian state of South Australia will shut down for six days from midnight Thursday, following a Covid-19 outbreak in Adelaide, the state's capital city.

South Australia Premier Steven Marshall announced Wednesday that the community would "pause" for six days to serve as a "circuit breaker" of the new outbreak.

The new measures: South Australians will be restricted from leaving their homes, even for outdoor exercise, unless they are an essential worker, South Australia Police Commissioner Grant Stevens said. 

A mandatory mask mandate will also be enforced, Stevens added.

All facilities such as schools, pubs, coffee shops and outdoor sports will be closed. Only essential services, like supermarkets, medical facilities and public transport will remain open. 

There are currently 22 Covid-19 cases linked to the Adelaide cluster, South Australia's Chief Health Officer Nicola Spurrier said. The cases are all considered to be linked to a worker in a medi-hotel, where international arrivals are required to quarantine for 14 days.

On Tuesday, local authorities ordered 4,000 people into quarantine in an attempt to contain the cluster.

South Korea reported 313 new coronavirus cases for Tuesday, the biggest daily jump since August 29, according to a Korea Disease Control Prevention Agency (KDCA) news release on Wednesday. 

Among the new cases, 245 were locally transmitted and 68 were imported. 

More than half of the new cases were from the greater Seoul area. The Seoul metropolitan area will tighten its social distancing measures from Thursday, limiting the size of school classes and religious gatherings.

South Korea has now recorded a total of 29,311 cases and 496 deaths, according to KDCA.

A mid-stage trial shows that a Chinese made Covid-19 vaccine seems to be safe, according to a study published in the Lancet Infectious Diseases Tuesday.

Sinovac, the Chinese company that makes the Coronavac vaccine candidate, tested it in a randomized controlled trial involving 700 healthy adult volunteers between April and May. None of the volunteers had a history of a Covid-19 infection. None had traveled in areas with a high rate of the disease.

Volunteers in the Phase 2 trial were divided into three groups. One group got a low dose of the vaccine, another got a higher dose and a third received a placebo.

This particular vaccine uses a chemically inactivated whole virus based on a sample taken from a patient in China. Most of the other coronavirus vaccines in development use biotechnology approaches to produce just a fragment of the virus. Using a whole, killed virus is an older, tried and true method that makes vaccine production slower and that doctors say can produce more side-effects.

The results: The vaccine was well tolerated at all the dose levels, and there didn’t seem to be any safety concerns, according to the researchers, which include experts from the Jiangsu Provincial Center for Disease Control and Prevention, China's National Institutes for Food and Drug Control, and Sinovac.

The most common complaint was pain at the injection site. One volunteer in the high dose group had a severe allergic reaction within 48 hours of the first dose, which researchers said may be related to the vaccine, but the volunteer was treated for the reaction and recovered within three days. The same volunteer did not have a similar allergic reaction to the second shot.  

Even at the lowest dose, volunteers who received the vaccine seemed to show a robust antibody response within 14 days of the second of two injections. The injections were given 14 days apart.  

What about efficacy? The levels of antibodies produced by vaccination were lower than in the volunteers who were infected by, and had recovered from, Covid-19 during the trial, but the researchers said they still expected it could provide protection. The study wasn’t designed to determine how effective it was.

There may be advantages to this vaccine, according to one researcher who worked at the company that made it. This vaccine only needs standard refrigeration. It also may remain stable for up to three years in storage.

The company is continuing its trials to determine how effective the vaccine is.

France has become the first country in Europe to top 2 million confirmed cases of coronavirus, according to data from Johns Hopkins University and the French national health agency.

In a statement on Tuesday evening, France's health agency director Jerome Salomon confirmed at least 2,036,755 total cases had been reported in the country.

While France has now registered the highest cumulative number of Covid-19 cases in Europe overall, Salomon noted that the current coronavirus reproduction rate in the country is now below one, while the daily number of new cases has declined in the past week.

According to the latest data from the national health agency, a total of 33,139 coronavirus patients are currently in hospital -- down by 327 since Monday -- with 4,838 of those in intensive care.

A further 1,219 coronavirus patients have died since Monday, the national health agency added, bringing the total death toll in France to 46,273.

The US Food and Drug Administration has called for a meeting of its vaccine advisory committee in three weeks to consider whether the agency should authorize two Covid-19 vaccines, according to a source familiar with the process. 

The FDA reached out last week to members of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, asking them to hold Dec. 8, 9 and 10 for meetings, according to the source. 

The agency could make a decision at the end of the meeting on Dec. 10 about whether to issue emergency use authorizations for the vaccines, the source said. 

Two companies, Pfizer and Moderna, say they will soon apply to the FDA for authorization for their Covid-19 vaccines, both of which have shown in initial data to be more than 90% effective against Covid-19. 

If the FDA authorizes the vaccines, they can then be immediately distributed to states, according to a presentation made last month at the US Centers for Disease Control and Prevention.

However, no one can be vaccinated until a CDC advisory committee reviews the data, recommends the vaccine, and says which groups will receive it first. 

If the FDA authorizes the vaccines, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel of experts, will meet within 24 to 48 hours, according to a CDC spokesperson. 

At that meeting, the committee will determine if everyone should get the vaccine, or if some people should be excluded. It will also decide which groups should get the vaccine first. 

Once ACIP issues its recommendations, vaccinations can be given. 

Next steps: The nation’s top infectious disease physician, Dr. Anthony Fauci, told CNN earlier this week the first vaccinations in the US could take place “towards the latter part of December.” 

States are currently working out the details of running vaccination clinics. The Pfizer vaccine is particularly complicated, since it must be stored at minus 75 degrees Celsius, and doctors’ offices and pharmacies typically do not have freezers that go that low. 

The first groups expected to receive the vaccine are health care workers, the elderly, essential workers such as police officers, and those with underlying medical conditions. 

The Pfizer vaccine trial has reached its safety milestone and the company is preparing to file for emergency use authorization, Pfizer CEO Albert Bourla said Tuesday.

Pfizer announced on Nov. 9 that its coronavirus vaccine appears to be more than 90% effective, based on early data.

But the company did not yet have enough data to seek emergency use authorization from the US Food and Drug Administration, which said it also wanted at least two months of safety data on at least half of a vaccine trial’s volunteers starting from when they got their second immunization.

Bourla said they are not yet sure how durable the protection from their vaccine will be. The Pfizer vaccine uses a messenger RNA, or mRNA, platform to produce an immune response.

“With the mRNA technology, you can boost as soon as you want,” said Bourla. People can be given an additional dose of a vaccine once immunity wears off, referred to as a boost.

Bourla said that a boost, if needed, would likely require only one dose.