The latest on the coronavirus pandemic and vaccines
Tags: Vaccines, Covid 19, Updates

US will ship 7.9 million doses to states in the next week if Moderna vaccine is authorized, official says

From CNN’s Lauren Mascarenhas

The US may ship 7.9 million coronavirus vaccine doses to states in the next week, Adm. Brett Giroir, US Health and Human Services Assistant Secretary, said on a call with reporters Thursday.

“Today, as I’ve said before, the end of the pandemic is in sight,” Giroir said. With two companies making vaccine, that will add to the supply that is slowly being rolled out.

“If the Moderna vaccine is authorized, we expect to ship 7.9 million additional doses of vaccines to states next week,” Giroir said.

On Wednesday, Health and Human Services Secretary Alex Azar said 2 million doses of Pfizer’s vaccine and 5.9 million doses of Moderna’s had been allocated for next week, in anticipation of Moderna’s vaccine winning US Food and Drug Administration emergency use authorization by the weekend.

“We still anticipate that every American will have the opportunity to be vaccinated by June,” Giroir said.

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He noted that the vaccination program aims to achieve long-term herd immunity, which might start to happen if 75 to 80% of Americans are immunized.

“This will essentially end the pandemic as we know it,” he predicted.

22 min ago

Covid-19 hospitalizations in Pennsylvania are double the state’s peak in spring

From CNN’s Kristina Sgueglia

Pennsylvania is reporting 6,346 patients hospitalized, double what it reported in the peak of the spring when the pandemic first took hold, officials said.

Of that number, 1,238 are in the ICU, Pennsylvania Health Department officials said in a news release.

The state reported an additional 9,966 positive cases.

Officials also marked an additional 224 deaths, down from the 278 reported Wednesday, which is the record high of one day additions.

The trend in the 14-day moving average of number of hospitalized patients per day has increased by nearly 5,200 since the end of September, the department noted in the release.

From Dec. 4 to Dec 10, statewide percent positivity was 16.2%.

The most up-to-date daily data is available on the department’s website.

37 min ago

Pfizer says there have been no production or shipment delays involving Covid-19 vaccine

From CNN’s Nadia Kounang

Vaccine maker Pfizer denied Thursday it is experiencing delays in making or shipping its coronavirus vaccine.

Pfizer CEO Albert Bourla tweeted that his company “is not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed.

This week we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. government to the locations specified by them,” he tweeted.

“We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses. We have continuously shared with Operation Warp Speed (OWS) and the U.S. Department of Health and Human Services through weekly meetings every aspect of our production and distribution capabilities. They have visited our facilities, walked the production lines and been updated on our production planning as information has become available,” Bourla added.

Pfizer said it is confident it can deliver 50 million doses globally this year and up to 1.3 billion doses next year.

58 min ago

Moderna says two allergic reactions during trials were not related to the vaccine

From CNN’s Jen Christensen

Dr. David Martin, the vice president of pharmacovigilance at Moderna, said the company will continue to monitor for allergic events, but hasn’t seen any reactions related to the Covid-19 vaccine during its late-stage clinical trial.

During the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting Thursday, Martin said there were two anaphylaxis reactions among the volunteers in Moderna’s late-stage trial, but the company does not think its vaccine-related.

“We have actively scrutinized our safety data to identify and analyze possible cases of anaphylaxis. We found no cases suggestive of anaphylaxis to mRNA 1273,” Martin said.

One severe allergic reaction was in the placebo group and one was in the group that got the vaccine.

The allergic reaction in the placebo group happened 10 days after the volunteer got their first dose of the placebo. Doctors believed the allergic reaction was a reaction to a dye used in the placebo.

The person in the vaccine group had a severe allergic reaction 63 days after they got the second dose of the vaccine. This person has a history of asthma and is allergic to shellfish.

1 hr 4 min ago

Kamala Harris will be vaccinated in public

From CNN’s MJ Lee and Jeff Zeleny

Vice President-elect Kamala Harris will receive the Covid-19 vaccine in a public setting, transition officials tell CNN. The exact timing and logistical details remain up in the air.

President-elect Joe Biden is likely to receive the vaccine early next week and he too, will do it in public.

What is also still unclear is whether both Biden and Harris might receive the vaccine in the same setting.

The commitment to getting vaccinated in public comes as the incoming Biden administration is focused on building public trust around the coronavirus vaccine as distribution gets underway.

Harris, in particular, has stressed the importance of doing this in communities of color, where there tends to be stronger distrust of vaccines.

“Frankly, it’s about listening to the people. I mean it’s about remembering history, and why people feel the way they do. And then also reminding us that this vaccine is just about one thing and one thing only: saving lives,” Harris said in an interview with ABC News this week.

1 hr 47 min ago

Moderna will establish a registry to track pregnancies during clinical trials

From CNN’s Amanda Watts

Moderna said it will establish a “pregnancy registry” to track pregnancies during clinical trials for its Covid-19 vaccine.

The company told US Food and Drug Administration vaccine advisers about plans to keep track of people who get vaccinated while pregnant.

“With respect to safety in the event of vaccine exposure during pregnancy, a developmental and reproductive study was completed in December 2020, with no adverse findings,” Dr. David Martin, vice president of pharmacovigilance at Moderna, told FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).

In documents released earlier this week ahead of the VRBPAC meeting, Moderna said 13 pregnancies were reported through Dec. 2. Six of the pregnancies were in the vaccine arm and seven were in the placebo arm.

“Given the limited human exposure to date in the phase three trial, we will establish a pregnancy registry that includes a cohort recruited from the general population,” he said.

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1 hr 55 min ago

Spain’s prime minister tests negative for Covid-19 after contact with Macron

From CNN’s Al Goodman and Claudia Rebaza

Spain’s Prime Minister, Pedro Sánchez, tested negative for Covid-19 on Thursday, his office announced.

Following Covid-19 protocols, Sánchez will quarantine until Dec. 24 after being in contact with French President Emmanuel Macron in Paris on Dec. 14, a statement released by his office reiterated.

“The Prime Minister will continue with his duties with the limitations that derive from his quarantine,” the statement adds.

King Felipe VI of Spain also had to quarantine for a period of ten days at the end of November after being in contact with someone who tested positive for Covid-19.

1 hr 58 min ago

New York City mayor says Covid-19 restrictions needed “sooner rather than later”

from CNN’s Kristina Sgueglia

Continuing to beat the drum on what he believes is necessary if numbers don’t turn around, New York City Mayor Bill de Blasio suggested restrictions will be necessary, and soon.

“If we don’t turn this around quickly the restrictions are the thing that stop the situation from getting worse,” de Blasio said.

“If you want to avoid them…wear a mask, practice distancing, do not travel, do not have large gatherings, be tough be disciplined,” he said.

All the metrics are just “too high” and “growing” he warned.

“I don’t like restrictions, none of us likes restrictions, but I think we need them sooner rather than later.”

De Blasio said he thinks restrictions need to be put into effect “soon based on the very consistent information we are seeing.”

“Certainly right after Christmas is a natural moment where the world slows down a little bit,” he said.

As he reiterated, the decision is up to the state and they remain in constant contact.

2 hr 4 min ago

Moderna has additional Covid-19 vaccine trials planned for children and cancer patients

From CNN’s Jen Christensen

Moderna says it will continue to investigate how its Covid-19 vaccine works in different patient populations, beyond the late-stage trial that is currently underway.

“We are initiating pediatric clinical trials, collaborating with the National Cancer Institute, to evaluate vaccine safety and immunogenicity of people with cancer, and will continue to collaborate with FDA and other agencies to gather additional long term safety data,” Moderna Chief Medical Officer Dr. Tal Zaks said Thursday.

He spoke at the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting that is considering Moderna’s Covid-19 vaccine for emergency use authorization in the United States.

2 hr 10 min ago

New York City hospital system suspends elective procedures as Covid-19 cases surge

from CNN’s Kristina Sgueglia

New York City Health + Hospitals has suspended elective procedures at its 11 hospitals, according to its CEO.

“We’ve made it clear that the only surgeries we will be doing are surgeries where they come in emergently such as car accidents or surgeries where somebodies health is directly affected such as when somebody has an infection,” CEO Mitch Katz said.

Necessary and emergency surgeries continue however, but consistent with the governor’s request, elective procedures have been canceled, he said.

“We do have the extra 25% capacity the state has asked us for.” Currently occupancy is at 65% in both ICU and in regular medical surgical beds, he said. “One third more patients than the patients we have would easily fit in without opening any extraordinary spaces.”

Katz says the hospitals are already participating in “level loading,” meaning moving patients from full hospitals to other hospitals with more capacity. He remarked that it’s been easier to move patients now because they are not as sick as they were in March or April, and the hospital system is moving them earlier in the process, he said.

Katz also added that they are committed to getting everybody in the 11 public hospitals vaccinated in three weeks.

2 hr 18 min ago

Israelis brace for possible third lockdown

From CNN’s Elliott Gotkine and Amir Tal

The number of daily coronavirus cases in Israel hit 2,802 on Wednesday — way above the 2,500 mark at which lawmakers said tightened restrictions would kick in.

The R-rate — the average number of people infected by a Covid-19-carrying individual — rose to 1.23.

The country’s so-called coronavirus cabinet will meet on Sunday to decide what to do.

Although a third lockdown is possible, it seems more likely the government will impose additional restrictions on commerce: closing shops, malls and markets that aren’t considered essential.

The night before the cabinet meets, after the end of the Jewish sabbath, Prime Minister Benjamin Netanyahu will be the first person in the country to be vaccinated with the Pfizer/BioNTech jab.

In a video message recorded at his home, where he’s self-isolating, he said:

“On Friday, I will leave quarantine and on Saturday evening I will go get vaccinated. I have asked to be the first person to get vaccinated in order to serve as an example and to persuade you that you can and should be vaccinated.”

President Reuven Rivlin will follow on Sunday, when he visits health workers at Hadassah Ein Kerem hospital in Jerusalem.

Along with leading political figures, medical professionals will also be among the first group of Israelis to be vaccinated.

2 hr 26 min ago

Moderna’s chief medical officer reveals key details on vaccine

From CNN’s Amanda Watts

The Moderna vaccine involves “no further mixing or dilution, while remaining stable for up to 12 hours at room temperature,” Moderna’s Chief Medical Officer, Dr. Tal Zaks, said on Thursday.

During the Vaccines and Related Biological Products Advisory Committee (VRBPAC), Zaks said the manufacturing process “does not use products of animal or human origin, and it does not contain preservatives or adjuvants.”

The Phase 3 study shows “the vaccine efficacy rate for symptomatic Covid-19 infection was 94.1%, with a 95% confidence interval lower bound of 89.3%,” Zaks said.

“Importantly, we also observed a dramatic reduction in severe cases. All of the 30 severe cases observed at the time of primary analysis occurred in people given placebo,” Zaks added.

Moderna says that a reduction in symptomatic cases “predicts a reduction in cases leading to hospitalization, intensive care and death.”

Moderna has done early phase clinical trials on infectious disease for several years, Zaks said. “We have had not seen a significant safety concern in any of our trials to date.”