December 8 coronavirus news

Drugmaker AstraZeneca's coronavirus vaccine candidate was found to have 70.4% efficacy in an interim analysis of Phase 3 trial results, published for the first time in a peer-reviewed journal.

The findings fall in line with the efficacy that AstraZeneca previously announced in November for its vaccine, developed in collaboration with the University of Oxford.

The analysis, published in the journal The Lancet on Tuesday, found that the vaccine's efficacy in trial participants who received two full doses of vaccine was 62.1%, and then efficacy in those who received a half dose followed by a full dose was 90%.

"Here, we present the first interim safety and efficacy data for a viral vector coronavirus vaccine, ChAdOx1 nCoV-19, evaluated in four trials across three continents, showing significant vaccine efficacy of 70.4% after two doses and protection of 64.1% after at least one standard dose, against symptomatic disease, with no safety concerns," the researchers wrote.

More on the study: The study includes data from trials conducted in the United Kingdom, Brazil and South Africa between April and November. The safety data are based on more than 20,000 participants and the efficacy data are based on more than 10,000 participants.

The study says that across all four studies, "the vaccine had a good safety profile." There were 175 severe adverse events in the trials total: 84 events among those who received the vaccine and 91 in the control group. "Three events were classified as possibly related to a vaccine," according to the study. Those included a case of haemolytic anaemia, transverse myelitis and high fever.

There were four deaths during the course of the trials, but all were unrelated to the vaccine, caused by a road traffic accident, blunt force trauma, homicide and fungal pneumonia.

Officials leading the White House's "Operation Warp Speed" effort to mass produce a coronavirus vaccine passed up a chance to purchase more than the current total of 100 million doses of the Pfizer vaccine as part of a concerted effort to keep the administration's options open to other vaccines being developed at the same time, an administration familiar with the situation said. 

The official said the decision was made as part of a plan to "diversify" the nation's vaccine arsenal through the purchase of millions of doses from Pfizer's rivals. At the time, officials at "Operation Warp Speed" had no idea the Pfizer vaccine was going to be this effective.  

"The plan was to diversify and don't put all your eggs in one basket," the official continued.

Now, the US simply may have to hope that the other vaccines being produced by other companies are just as effective as the Pfizer doses, the official said.

If the other vaccines being manufactured by Pfizer's rivals don't perform at the same level, it could have a detrimental effect on inoculating the American public, the official said, noting it may be difficult to match Pfizer's efficacy rate.

"It's going to look bad," the official continued, if the other vaccines don't perform as well as the doses from Pfizer. But the official said the hope is that the other vaccines will be as effective as the Pfizer doses.

Additional reporting from CNN's Ali Main

Arizona has posted a record-setting number of new Covid-19 cases today — 6,973 new cases, according to the state's data dashboard.

Today's case count replaces the old record-high of 5,442 cases that was set on Dec. 3.

Arizona did report a massive 10,322 new Covid-19 cases on Dec. 1, but the state's health department said "this large number of newly reported cases is a result of the extended four-day weekend.” Because of the lag in the data reporting, it is not clear how those cases break down over the Thanksgiving holiday days.

The state has been experiencing a surge in Covid-19 cases in the last few weeks with daily case counts regularly topping 3,000 new Covid-19 cases. 

Arizona has reported a total of 378,157 cases of Covid-19 and 6,973 reported deaths to the disease since the pandemic began. 

Note: Some of these numbers were released by the Arizona Department of Health Services and may not line up exactly in real time with CNN's database drawn from Johns Hopkins University and the Covid Tracking Project.

New York City Mayor Bill de Blasio said that while the world is 10 months into the pandemic crisis, there is finally an “end in sight” as “next week the vaccine will be here in NYC.”

“We have one more big battle ahead,” he said, stressing that everyone just needs to get through the next few winter months.

Remember: The US Food and Drug Administration's Vaccine and Related Biological Products Advisory Committee will meet on Thursday to discuss Pfizer's application for emergency use authorization for its coronavirus vaccine candidate.

A similar meeting is scheduled next week for Moderna's vaccine candidate. FDA officials say their decisions on the vaccines could come days to weeks after the meetings — it depends on what questions come up.

The UK began administering the first doses of the Pfizer/BioNTech vaccine outside clinical trials today, just days after the country approved the vaccine last week.

The US has not yet approved any coronavirus vaccine: The US Food and Drug Administration's Vaccine and Related Biological Products Advisory Committee will meet on Thursday to discuss Pfizer's application for emergency use authorization for its coronavirus vaccine candidate, but FDA officials say their decisions on the vaccine could come days to weeks after the meetings — it depends on what questions come up.

So why was the UK first? The vaccine was granted emergency authorization in the UK by its independent regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), which has played a crucial part in the process.

The MHRA began a rolling review of Pfizer and BioNTech data from October, with each "package" of data reviewed as soon as it became available. This allowed regulators to examine the data in detail before a final authorization application was submitted.

According to the MHRA, a rolling review "can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible."

This approach helped accelerate the authorization process and a formal review of all the necessary information began in the UK on Nov. 23, leading to last week's approval announcement.

"I think the advantage is that the MHRA has been undertaking a rolling review, which means that as Pfizer accumulated data on how they manufactured the vaccine ... MHRA could keep pace with that," David Salisbury, associate fellow in Chatham House's Global Health Programme, told CNN. "That has allowed the MHRA to be nimble and keep pace."

Senate Majority Leader Mitch McConnell summed it up on Monday: "We are down to the wire."

If there is going to be a stimulus deal, if millions of Americans who depend on expanded unemployment benefits are going to continue getting that help, Congress has to come to an agreement and soon.

Here's a look at where stimulus negotiations stand:

The sticking point: The issue for the bipartisan group is liability insurance. That's why you didn't see them unveil legislative text Monday, and it is why the group talked again into the night for several hours. For months, including liability protection was standing in the way of the talks between House Speaker Nancy Pelosi and Treasury Secretary Steve Mnuchin, and it is still standing in the way of benefits for millions of Americans.

This is the item that Republicans are insisting on, not unlike how Democrats have been pushing for months to ensure state and local governments get another round of funding. Democrats know they don't get state and local funding without finding a path forward on liability and Republicans know they don't get liability without something for state and local.

Aides say the meeting Monday night was productive and it served as an opportunity for members to vent and lay out each party's side of the liability issue. But there still isn't a resolution.

Areas of potential compromise: It's possible that if senators can't find an agreement, the bipartisan group could decide to take out state and local and liability and move forward without them. Republican Sen. Mitt Romney of Utah told CNN that Monday night. McConnell on the floor Monday told Democrats that Congress does "not need to resolve every one of our differences to get badly needed relief out the door."

The big question is, could you actually get enough Democrats to vote for a package that did not include state and local funding? Most members I've asked about this have said they can't agree to anything without it.

Where most lawmakers do agree:

What could come next: Now that there is an extra week on the congressional calendar, some of the pressure might be off the bipartisan group to come up with a deal so quickly.

The reality is that the momentum visible last week was a direct result of pressure folks were feeling with the Dec. 11 spending deadline. This stimulus package was always going to be attached to the long-term spending deal and with that deadline kicked off until Dec. 18, there is more time.

More time can be good in that it gives negotiators room to find a middle ground and in this case it gives a group of lawmakers who are operating without committees, time to write a bill. But, it can also backfire. Congress operates best and most efficiently when its back is against the wall. More time means that these talks can drag out, giving people more time to nitpick and change their minds.

Read more here.

As the coronavirus pandemic continues to rage in many parts of the world, the UK and the US are taking important steps this week in their vaccination efforts.

If you're just reading in now, here's where things stand:

An advisory committee to the US Food and Drug Administration on Tuesday released a briefing document detailing data on Pfizer and BioNTech's Covid-19 vaccine candidate, which will be considered this week for emergency use authorization in the United States.

The document confirms that the vaccine's efficacy against Covid-19 was 95%, occurring at least seven days after the second dose – an efficacy that had been previously reported by Pfizer. The proposed dosing regimen for the vaccine is to administer two 30-microgram doses 21 days apart.

However, the document also notes that the vaccine, called BNT162b2, appears to provide "some protection" against Covid-19 following just one dose.

The document describes the efficacy of Pfizer's vaccine in the time between the first and second dose as 52.4%, but the document notes that "the efficacy observed after Dose 1 and before Dose 2, from a post-hoc analysis, cannot support a conclusion on the efficacy of a single dose of the vaccine, because the time of observation is limited by the fact that most of the participants received a second dose after three weeks."

In other words, "the trial did not have a single-dose arm to make an adequate comparison."

The document goes on to detail the safety profile of the vaccine as "favorable" and notes that the most common adverse reactions to the vaccine have been reactions at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.

Severe adverse reactions occurred in less than 4.6% of participants, were more frequent after the second dose and were generally less frequent in older adults as compared to younger participants, according to the document. The document adds that swollen lymph nodes also may be related to vaccination.

A total of six participants died during the trials, and "all deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate."

The document will be discussed in a meeting on Thursday, where the FDA's Vaccine and Related Biological Products Advisory Committee will provide recommendations to the FDA on whether the vaccine is effective in preventing Covid-19 in people 16 and older and whether the potential benefits of the vaccine outweigh the risks.

"The committee will also discuss what additional studies should be conducted by the vaccine manufacturer following issuance of the EUA to gather further data on the safety and effectiveness of this vaccine," according to the document.

When asked by NBC's Savannah Guthrie if Queen Elizabeth and Prince Philip would receive a Covid-19 vaccine on camera, British Foreign Secretary Dominic Raab said that's not likely, but they will get vaccinated following the phased approach.

Due to their ages, Queen Elizabeth, 94, joins her husband Prince Phillip, 99, in being among the most vulnerable groups first in line for the Pfizer/BioNTech vaccine as it rolled out today in the UK.

Last week, CNN reported that former Presidents Barack Obama, George W. Bush and Bill Clinton are volunteering to get their Covid-19 vaccines on camera to promote public confidence in the vaccine's safety once the US Food and Drug Administration authorizes one.