December 11 coronavirus news

Vaccine advisers to the US Food and Drug Administration voted Thursday to recommend the agency grant emergency use authorization to Pfizer and BioNTech's coronavirus vaccine, and the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is set to meet this weekend to consider if the CDC should offer the vaccine to the American public.

But even as the vaccine process progresses, it's likely the US won't see any meaningful, widespread impacts from vaccinations until well into 2021.

Just how quickly the country will be able to recover depends on how quickly Americans get vaccinated — and how many people are willing to get the vaccine.

"If we have a smooth vaccination program where everybody steps to the plate quickly, we could get back to some form of normality, reasonably quickly. Into the summer, and certainly into the fall," Dr. Anthony Fauci told CNN Thursday.

"My hope and my projection is that if we get people vaccinated en masse so that we get that large percentage of the population, as we get into the fall, we can get real comfort about people being in schools, safe in school — be that K-12, or college," he added.

Key players in the vaccine decision process have been told to expect the US Food and Drug Administration to issue an Emergency Use Authorization for Pfizer/BioNTech's vaccine Saturday, according to a federal government source close to the situation.

The source cautioned that anything is possible, and the FDA decision could still come today. 

The Saturday timing is in line with a meeting set for Sunday by the Advisory Committee on Immunization Practices, whose vote will inform a final decision by the US Centers for Disease Control and Prevention. 

The FDA EUA allows shipping to begin, but shots still can’t be administered until the US CDC advisory committee recommends the vaccine.

The final step in the process is for CDC Director Dr. Robert Redfield to sign off on the committee recommendation. The source expects that to happen within hours of the Sunday meeting.

Vaccine advisers to the US Food and Drug Administration voted Thursday to recommend the agency grant emergency use authorization to Pfizer and BioNTech's coronavirus vaccine.

While the vote is an important step in the vaccine authorization and distribution process, it doesn't mean the vaccine will be authorized immediately.

Here's what happens next:

An important note: An EUA is short of a full approval. Pfizer would have to file a separate application for full FDA approval for its vaccine.

“Just a little bit ago, the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine,” US Health and Human Services secretary Alex Azar told ABC’s George Stephanopoulos on Friday.

HHS confirmed to CNN that Azar was referencing a tweet posted on Friday morning, which links to a Friday US Food and Drug Administration news release from the FDA’s Dr. Stephen Hahn and Dr. Peter Marks.

Azar said that “in the next couple of days, probably,” as they work to negotiate with Pfizer and get information the doctors need to prescribe it appropriately, “we should be seeing the authorization of this first vaccine.”

Azar said that they will work with Pfizer to get it shipped out and “so we could be seeing people get vaccinated Monday, Tuesday of next week.”

“So, it’s very close. It’s really just the last dotting of I’s and crossing of T’s,” Azar added.

German Economy Minister Peter Altmaier has warned that new coronavirus infections are growing “exponentially again” and said politicians need to “act now” in order to curb the spread of coronavirus.

Speaking on Public TV on Thursday, Altmaier said "the exponential growth is reoccurring, and this means we urgently have to act now if do not want to get things entirely out of control."

''We need to see the infections numbers drop significantly by the beginning of next year," Altmaier added.

On Friday, Germany recorded a record number of infections and a record death toll over a 24-hour period, with 29,875 new cases and 598 deaths.

Data from the German Interdisciplinary Association for Intensive and Emergency Medicine (DIVI) showed Thursday the number of Covid-19 patients admitted to intensive care units in Germany also reached an all-time high.

DIVI reported 4,339 patients being treated in intensive care facilities. Nearly 60% of patients in ICUs need ventilation and around 4,753 ICU beds are still vacant, figures showed.

On Thursday, the country's agency for disease control, the Robert Koch Institute, warned people to reduce contacts by more than 60% on their own or face tougher restrictions.

Weeks of a partial national lockdown have not slowed the spread of coronavirus infections enough.

Earlier this week German Chancellor Angela Merkel said she wants to implement a full lockdown for as long as two weeks after Christmas to bring down infection numbers.

Merkel is set to meet with Germany's sixteen federal state premiers Sunday to set out a coordinated plan on a full potential nationwide lockdown.

British and French pharmaceutical giants GlaxoSmithKline and Sanofi Pasteur said Friday the release of their coronavirus vaccine would be delayed until late 2021 after interim results showed “insufficient immune response” in the elderly.

“Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups,” a joint press release on their websites read.

Thomas Triomphe, head of Sanofi Pasteur, said the companies were “disappointed by the delay announced today,” adding that they “have identified the path forward."

“No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic,” Triomphe said.

Roger Connor, President of GSK Vaccines added: “The results of the study are not as we hoped,” and that it was now “clear that multiple vaccines will be needed to contain the pandemic.”

The two companies said they are now planning a new phase 2b study with an improved antigen formulation in February of next year, which could be followed by a global phase 3 study potentially starting in Q2 2021. The phase 3 studies were initially expected to start this month.

GSK and Sanofi said positive results from these phases “would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.”

The two drug makers said they have updated governments and the European Commission on the delay “where a contractual commitment to purchase the vaccine has been made.”

This summer, the French and British giants won a commitment from the US federal government to pay up to $2.1 billion to help them move forward with their proposed joint coronavirus vaccine, as part of Operation Warp Speed.

Pharmaceutical giant AstraZeneca is launching a joint clinical trial with the makers of Russian Sputnik V to test the combination of coronavirus vaccines, according to a statement published on AstraZeneca’s Russian website on Friday. 

“Today we announce a clinical trial programme to assess safety and immunogenicity of combination of AZD1222, developed by AstraZeneca and Oxford University and Sputnik V, developed by Russian Gamaleya Research institute. It will begin enrolling adults aged 18 years and older,” AstraZeneca said.

According to the British-Swedish drugmaker, a combination of the two coronavirus vaccines may help in generating “wider protection through a stronger immune response and better accessibility.” 

Both vaccines are adenoviral vector vaccines that contain “genetic material of SARS-CoV-2 virus spike protein,” AstraZeneca’s statement added. 

The Moscow-based Gamaleya Institute and Russian Direct Investment Fund (RDIF) --which sponsored the development of Sputnik V -- said in a statement that they offered AstraZeneca the use of “one of the two vectors of the Sputnik V vaccine in additional clinical trials of its own vaccine,” which is expected to commence before the end of this year.

Russian vaccine Sputnik V uses human adenovirus, while AstraZeneca’s AZD1222 is based on chimpanzee viral vector. 

Russia registered Sputnik V in August ahead of key large-scale phase III trials necessary to establish the vaccine’s efficacy and safety. While phase III trials are currently ongoing, the country is already moving towards mass vaccination with the head of Gamaleya Institute saying that over 150,000 Russians have been inoculated so far, according to state-run news agency RIA Novosti.

Hong Kong Chief Executive Carrie Lam on Friday said her government has signed advanced purchase agreements for the Sinovac and BioNTech-Pfizer Covid-19 vaccines.

Based on a two-dose regime, the city intends to procure 7.5 million doses of the BioNTech-Pfizer vaccine, and 7.5 million doses of the Chinese Sinovac vaccine. Lam told the Friday press conference vaccines would be provided free to Hong Kong’s 7.5 million strong population.

Lam said the government was hoping to reach a third agreement with AstraZeneca and is looking for a fourth supplier.

“The first million are expected to arrive in Hong Kong in January next year, earliest,” Lam said of the Sinovac vaccine, which only requires one dose.

"The other one is in Germany, BioNtech & Pfizer, and this vaccine uses another different another technology that is mRNA, again 7.5 million doses will be available. The first batch of 1 million doses will arrive in Hong Kong, in the first quarter next year, earliest”, Lam said.

Elderly citizens, sufferers of chronic illnesses and care workers from nursing homes will be first to receive the vaccine, Lam said.

Hong Kong diagnosed 86 new Covid-19 cases in the city on Thursday, five of which are imported and 37 are untraceable.

Thursday saw a major milestone in the authorization process for a Covid-19 vaccine in the US -- a milestone that comes as the country is deep into a health crisis that is only worsening.

The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee voted to recommend the agency grant emergency use authorization (EUA) to Pfizer and BioNTech's Covid-19 vaccine. The agency will now decide whether to accept that recommendation, but has signaled it is likely to do so.

Officials are scheduled to meet again next week to discuss Moderna's EUA application.

The vote, Dr. Anthony Fauci said, is a "very important step."

While the green light for a Covid-19 vaccine will offer a light at the end of the tunnel, leading experts have warned the worst days of the pandemic are still ahead for the US. More case surges are likely to take shape as a result of Thanksgiving travels and gatherings that could drive infection numbers even higher. The US is now averaging more than 210,000 new cases daily.

Hospitalization numbers break records daily -- with Thursday reporting the highest number of Covid-19 patients nationwide since the pandemic's start: more than 107,200, according to the COVID Tracking Project. A CNN analysis of newly released data from the US Department of Health and Human Services showed that at least 200 hospitals across the US were at full capacity last week. And more than 90% of ICU beds were occupied in a third of all hospitals.

And the virus is claiming more American lives each day than ever before. Wednesday saw the highest daily death toll the US has reported since the start of the pandemic, with a staggering 3,124 Covid-19 deaths. More than 2,700 deaths were reported Thursday.

"We are in the time frame now that probably for the next 60 to 90 days, we're going to have more deaths per day than we had in 9/11," said Dr. Robert Redfield, director of the Centers for Disease Control and Prevention (CDC).

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