October 6 coronavirus news

The US Food and Drug Administration posted guidance Tuesday for companies hoping to get emergency use authorization (EUA) for coronavirus vaccines, and said they will have to include at least two months of follow-up after volunteers get their second dose of vaccine.

That would mean no company could seek an EUA before mid-November, because the vaccines furthest along in clinical trials – those made by Pfizer and Moderna – both require waiting either 21 or 28 days between doses.

"Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research. 

“The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."

The FDA earlier Tuesday posted discussion documents for vaccine advisers with similar language.

Vermont is battling a Covid-19 outbreak among migrant workers at an apple orchard, state officials announced Monday. 

Champlain Orchards in Addison County had 27 workers test positive over the weekend, Vermont Health Commissioner Dr. Mark Levine said Tuesday. The commissioner had previously announced 26; one more test result came in after the initial announcement.  

The first positive case was discovered last week. The case came toward the end of the migrant workers' quarantine period after arriving in the state in mid-September, and the person is believed to have become ill outside of Vermont, according to Dr. Levine.

State officials said that the orchard owner was complying with guidance and that apples were disinfected before being sold.

Vermont has had the fewest Covid-19 cases of any state, with only 1,821 cases, according to Johns Hopkins University.

The state saw no Covid-related deaths or ICU admissions in September, according to state Department of Financial Regulation Commissioner Michael Pieciak.

Bars, restaurants and stores in the German capital Berlin will have to shut down between 11 p.m. and 6 a.m. starting Saturday, the city’s senate decided on Tuesday. 

The move comes as coronavirus infections in several districts have been soaring. 

Pharmacies and service stations are exempt from the new rules which the senate says will be in place until at least Oct. 31, according to Berlin’s official website. 

The number of people allowed to gather in a group in the night hours between 11 p.m. and 6 a.m. will be limited to five and no more than ten people at a time will be allowed to attend gatherings indoors. 

The move comes as coronavirus infections in Germany remain on the rise. 

The country recorded more than 2,600 new cases on Tuesday according to Germany’s center for disease control. 

The number of patients requiring intensive medical care is also steadily rising, official data shows.

House Speaker Nancy Pelosi issued a statement reacting to a series of tweets from President Trump announcing he was pulling the plug on stimulus negotiations. 

"Clearly, the White House is in complete disarray," she said.

"Walking away from coronavirus talks demonstrates that President Trump is unwilling to crush the virus, as is required by the Heroes Act. He shows his contempt for science, his disdain for our heroes — in health care, first responders, sanitation, transportation, food workers, teachers, teachers, teachers and others — and he refuses to put money in workers’ pockets, unless his name is printed on the check," she continued.

Some background: The decision to pull the plug on the talks is a major blow to Americans still struggling with the fallout from the once-in-a century pandemic and endangers an economic recovery that for months was driven by the initial $2.2 trillion stimulus passed by Congress in the spring.

With that money largely spent and gone, economists have warned more support is imperative in the months ahead.

While Treasury Secretary Steven Mnuchin and Pelosi were still far apart on a final agreement, according to multiple people involved, they were still very much in negotiations — with the two scheduled to talk by phone Tuesday afternoon and having continued to trade paper and legislative text over the last several days.

The first indications of whether early coronavirus vaccine candidates are safe and effective won’t be ready until November or December, Dr. Moncef Slaoui, chief adviser to the federal government’s Operation Warp Speed, said Tuesday.

“First wave with the RNA vaccines imminently November/December, a second wave with the non-replicating vectors vaccine In January or February,” he said, adding that the third wave with a protein platform is expected in March or April. 

Slaoui said that the expectation is that companies will file for emergency use authorization or full approval of their vaccines following the readouts.

President Trump has ordered his negotiators to halt negotiations over a new stimulus package. 

“I have instructed my representatives to stop negotiating until after the election when, immediately after I win, we will pass a major Stimulus Bill that focuses on hardworking Americans and Small Business," he tweeted.

Trump tweeted shortly after a private conference call with Senate Majority Leader Mitch McConnell, House GOP Leader Kevin McCarthy and Treasury Secretary Steven Mnuchin, the administration’s top negotiator.

The decision to pull the plug on the talks is a major blow to Americans still struggling with the fallout from the once-in-a century pandemic and endangers an economic recovery that for months was driven by the initial $2.2 trillion stimulus passed by Congress in the spring. With that money largely spent and gone, economists have warned more support is imperative in the months ahead. 

While Mnuchin and House Speaker Nancy Pelosi were still far apart on a final agreement, according to multiple people involved, they were still very much in negotiations – with the two scheduled to talk by phone on Tuesday afternoon and having continued to trade paper and legislative text over the last several days. 

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All public, private, charter, and religious schools and educational facilities in two areas in Orange County, New York, will be immediately closed for at least two weeks, according to a Monday order from the Orange County Commissioner of Health.

The order states that the village of Kiryas Joel and the town of Palm Tree reported a three-day average Covid-19 positivity rate of 27.6% and that all schools will not be allowed to resume without clearance from the county health department. 

County officials said that the schools will continue to be closed until the the area’s seven-day rolling average positivity rate is below 9% and no transportation would be provided to students residing in those locations to schools or services in other communities. 

Schools that provide in-person group special education or pre-school will also be closed for the same amount of time, the order states.

Orange County currently has 12,493 Covid-19 cases, with an overall county positivity rate of 7.4%, according to New York state data. 

Syracuse University reported 13 new cases of Covid-19 on Tuesday, saying the cluster appears to have started after off-campus parties late last week. The new cases can be traced "directly or indirectly to this event," according to a statement.

"Our initial investigation suggests that this emerging cluster is the result of one or more students returning to campus after traveling outside Central New York to visit another college late last week," wrote Vice Chancellor for Strategic Initiatives and Innovation J. Michael Haynie. "We are working closely with the Onondaga County Health Department to quickly identify and isolate all those potentially impacted and at risk because of this unfortunate series of events."

The overall number of positive Covid-19 cases is now 25, according to Syracuse's online Covid-19 dashboard, meaning this cluster accounts for more than half of positive cases for the whole university.

The university is asking any students who attended last weekend's gathering to shelter in place and not attend classes.

Boeing expects that demand for new commercial airplanes will fall over the next decade due to the impact of Covid-19, cutting its 2019 projections by 11%.

The company said in a press release Tuesday that the new projection amounts to 18,350 commercial planes over the next ten years, valued at about $2.9 Trillion.

The company forecasts 43,110 commercial aircraft deliveries over the next 20 years, down 2% from the 44,040 projected a year ago. 

However, Boeing says air cargo demand is “a relative bright spot in 2020,” expecting it to grow 4% annually.