September 8 coronavirus news

The pharmaceutical company Inovio plans to begin a Phase 2/3 clinical trial of its Covid-19 vaccine candidate this month, according to company president and CEO Dr. Joseph Kim.

How it works: Inovio's vaccine technology works by delivering particles of DNA directly into cells, triggering an immune response to the novel coronavirus inside the cells.

The Phase 2/3 clinical trial was first announced in August on an earnings call.

Inovio plans to enroll 6,000 to 10,000 volunteers in the study. That’s less than the 30,000 volunteers who are being enrolled in clinical trials for several other Covid-19 vaccine candidates.

Kim said the trial will be smaller than others because they’ll be targeting high-risk people, such as factory workers.

In August, Inovio shared results of small a Phase 1 clinical trial involving 40 volunteers. Side effects were mild, and the vaccine showed evidence of neutralizing antibodies and T cell responses.

The data has not yet been published in a peer-reviewed medical journal.

Inovio’s Covid-19 vaccine is being funded, in part, by the US Department of Defense, the Bill & Melinda Gates Foundation, and The Coalition for Epidemic Preparedness Innovations.

The company has not received funding from Operation Warp Speed, the Trump administration’s initiative to fast-track the development and delivery of a Covid-19 vaccine.

Three Phase 3 trials have already started in the US. Two other companies are also scheduled to begin Phase 3 trials this month, according to Moncef Slaoui, chief adviser of Operation Warp Speed.

Sanofi and GlaxoSmithKline expect to start a Phase 3 trial in the US by the end of the year.

Officials in Hartford, Connecticut, gave more information about the cyberattack against city systems this weekend, but did not announce a definitive start date for schools. 

On Saturday, more than 200 of Hartford's 300 servers experienced a ransomware cyberattack, according to Mayor Luke Bronin.

At this time, no private or personal data has been stolen, and the city's information technology service, Metro Hartford Innovation Services, is working to restore government systems, he said. Bronin said this is one of the most significant cyberattacks on the city in the last five years. 

The city's school bus routing service was one of the most heavily impacted systems the school district experienced, Bronin said. While they originally thought the system would be online and ready to go by this morning, it became clear last night that it was not the case.

The student information system Power School was also compromised in the attack, but was fully restored as of midnight last night, said Dr. Leslie Torres-Rodriguez, the superintendent of Hartford Public Schools. She also noted that Innovation Services is checking every desktop at each school to make sure they are not compromised. 

Torres-Rodriguez said they are not sure when school will officially start but will keep families updated on their progress.  

Police are investigating the attack and are in communication with the FBI on the matter, said Hartford Police Chief Jason Thody. While some public safety services were impacted, there were no issues with 911 calls or dispatch, he said.  

Bronin noted that due to investing in half a million dollars in cybersecurity services last year, the attack had a smaller impact than it could have.

Dr. Stephen Hahn, commissioner of the US Food and Drug Administration, said in a Twitter thread on Tuesday that he will be using the social media platform as a way to highlight the work the FDA is doing around a Covid-19 vaccine.  

He said that through Twitter and other venues, the agency will continue to “underscore that only science and data will drive FDA’s decisions,” adding that FDA staff will only authorize or approve a vaccine if it meets the high safety and efficacy standards expected by Americans.

While the agency is committed to expediting work around the vaccine, the FDA will not cut corners and have not lost sight of its responsibility to ensure that decisions related to all medical products, including vaccines, are based on science and data, he said.

Hahn tweeted that the FDA has made it clear through guidance what data needs to be submitted to meet regulatory standards, something he called “particularly important” as many people have expressed concerns about vaccine development efforts.

The FDA is also committed to an evaluation process that’s as transparent as possible, with an FDA advisory committee of independent experts meeting in October to publicly discuss vaccine development, Hahn tweeted.

He encouraged Twitter users to follow the hashtag #FDAVaccineFacts as the agency highlights different parts of the development and evaluation process. 

Democratic vice presidential nominee Kamala Harris told CNN affiliate WISN that she would trust a vaccine under President Trump, if “the public health professionals and the scientists told us that we can trust it,” dropping the clause she has previously used that she would not trust a vaccine under Trump.

Asked by WISN she would trust a vaccine under Trump, Harris first answered, “I pray we have a vaccine as quickly as possible that is approved by the scientists and the public health professionals.”

Pressed again, she said this:

On Sunday, Harris wouldn’t clearly answer CNN’s Dana Bash whether she would in fact take a vaccine if produced before Election Day. Harris instead said she wouldn't trust Trump as a credible source of information on a vaccine. 

“I will say that I would not trust Donald Trump and it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he's talking about,” Harris said Sunday. “I will not take his word for it. He wants us to inject bleach. No, I will not take his word.” 

Those comments drew criticism from both the GOP and President Trump, who called on her to apologize. 

Yesterday, her running mate Joe Biden, when asked a similar question said if he could get a vaccine, he'd take it tomorrow, even if it cost him the election.

Pennsylvania restaurants can increase their indoor capacity to 50% beginning Sept. 21, the governor said Tuesday.

Gov. Tom Wolf is requiring restaurants to commit to complying to public health safety guidelines by submitting through a self-certification process.

Restaurants must complete the online self-certification by Oct. 5.

Starting Sept. 21, restaurants with alcohol sales will stop those sales at 10:00 p.m. local time, Wolf's office said in the release.

Texas Gov. Greg Abbott issued a proclamation extending the Disaster Declaration for all counties in the state in response to Covid-19.

The extension was signed on Monday. The original proclamation was issued on March 13 and has been renewed on a monthly basis since. 

The US has recorded more than 6.3 million cases of the virus since the pandemic began earlier this year, according to the latest tally from Johns Hopkins University.

But today — the day after Labor Day in the US and the unofficial start of fall — some hallmarks of fall and other businesses are starting to reopen.

Here's a look at some of the things that are reopening this week or recently opened their doors again:

Senate Majority Leader Mitch McConnell announced that he will introduce the new Republican scaled-back stimulus plan on Tuesday, acknowledging the bill does not have everything that Republicans want in it. 

What happens next: A procedural vote to bring up the plan could happen as soon as this week, McConnell said. 60 votes would be needed to overcome the Democratic filibuster and advance the proposal, and the plan is far short of securing the necessary votes. 

CNN also reported earlier this morning that Republicans privately acknowledge they have not yet won the backing of 51 of their members for their party’s stimulus proposal. 

This comes after McConnell offered a $1 trillion dollar plan in July, but Republicans were badly divided over that proposal and he never brought that plan up for a vote.

Hartford Public Schools in Connecticut said it has postponed the opening of schools for both in person and online learning today, citing a ransomware virus that caused an outage of critical systems within the network infrastructure.

In a statement posted on their official website, officials note that the system in part communicates transportation routes to the bus company “and it is preventing our ability to operate schools on Tuesday.”

Officials are working to restore the system.