US FDA panel recommends Covid-19 vaccine authorization

By Julia Hollingsworth, Adam Renton, Emma Reynolds, Nada Bashir, Melissa Macaya and Meg Wagner, CNN

Updated 7:50 a.m. ET, December 11, 2020
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8:42 a.m. ET, December 10, 2020

Moderna starts Phase 2/3 trial of Covid-19 vaccine in US adolescents

From CNN's Jacqueline Howard

Vaccine maker Moderna announced on Thursday that the first adolescents, ages 12 to under 18, in its Phase 2/3 study of coronavirus vaccine candidate mRNA-1273 have been given vaccine doses.

The study, conducted in collaboration with the Biomedical Advanced Research and Development Authority, will evaluate the safety and efficacy of administering two vaccine doses 28 days apart, the announcement said.

Moderna noted that it intends to enroll 3,000 adolescents in the United States. 

"We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy adolescents in the U.S. Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year," Moderna CEO Stéphane Bancel said in the announcement.

"We are encouraged by the interim and primary analyses of the Phase 3 COVE study in adults ages 18 and above and this adolescent study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population. We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting," the announcement continued.

10:00 a.m. ET, December 10, 2020

FDA's initial assessment of Pfizer's vaccine is that it meets criteria, commissioner says 

From CNN's Naomi Thomas

from NBC
from NBC

It’s possible that the US Food and Drug Administration could issue advisories similar to the UK in regard to people with allergies, if and when the Pfizer vaccine receives authorization, FDA Commissioner Dr. Stephen Hahn said Thursday. But FDA’s initial assessment, he said, is that the vaccine meets their criteria.

“We’re working with our UK partners now to understand exactly what happened with respect to those reactions. We take this seriously,” Hahn told NBC’s Savannah Guthrie. 

Hahn said one of the reasons that they do “such a careful review, line by line, of the patient data is because our label around a vaccine will not just say who should get it, but who should not receive the vaccine.”

Guthrie then asked if allergic reactions like the ones in the UK were seen in the clinical trials.

Hahn said that was being discussed today – “so stay tuned for that.”

“What I can tell you is that the side effects associated with the vaccines are very carefully recorded,” he said. FDA data was put out on Tuesday and will be discussed in the meeting Thursday.

 “We think that, our initial assessment is that this is a vaccine that is, that does meet our criteria, but we do want to hear from the vaccine advisory committee,” he said.
8:25 a.m. ET, December 10, 2020

North Korea tells WHO it has tested more than 9,000 people and found no virus cases

From CNN's Yoonjung Seo in Seoul

As part of preventative measures against coronavirus, a worker takes the temperature of an attendee ahead of a performance by North Korea's National Acrobatic Troupe in Pyongyang, North Korea, on November 16.
As part of preventative measures against coronavirus, a worker takes the temperature of an attendee ahead of a performance by North Korea's National Acrobatic Troupe in Pyongyang, North Korea, on November 16. Kim Won Jin/AFP/Getty Images

North Korea says it has tested over 9,000 people and found no positive virus cases, according to data Pyongyang provided to the World Health Organization (WHO).

A total of 18,472 samples were taken from 9,373 people who underwent a "reverse transcription-polymerase chain reaction" test (the common diagnostic swab test) over 10 days and with no positive cases detected.

Among those tested, 4,275 people had developed a fever as they were quarantined and the others tested were health workers deployed at quarantine stations and involved in collecting samples, according to the report.

North Korea has released 33,044 people from quarantine as of November 26, according to data released by WHO.

Independent testing: North Korea independently conducted the tests, and the Ministry of Public Health of North Korea provided the data to WHO, which released the statistics on Thursday. 

The North Korean government has maintained no positive cases of Covid-19 have been detected in the country, a claim widely questioned by experts.

8:22 a.m. ET, December 10, 2020

“We intend to act quickly,” FDA commissioner says of considering Pfizer’s vaccine for an EUA

From CNN Health’s Naomi Thomas


“I’m not going to prejudge what the advisory committee – which is a non-binding committee of scientific experts – will say to us. We’ll have to see what the scientific and medical discussion is today,” US Food and Drug Administration Commissioner Dr. Stephen Hahn told NBC’s Savannah Guthrie Thursday, when asked if authorization of Pfizer’s vaccine could come as early as today or tomorrow.

The FDA's Vaccines and Related Biological Products Advisory Committee is meeting today to consider emergency use authorization for Pfizer and BioNTech's coronavirus vaccine.

 “Our plan is to take their recommendations into account for our decision making, and make a decision shortly thereafter,” Hahn continued. “Again, it really depends upon the complexity of the issues discussed, but we intend to act quickly.”

When asked about if the committee could raise questions or say that decisions need to be delayed – and whether the FDA could decide to move forward anyway – Hahn said that scenarios like that have been experienced by the agency.

“We have the advisory committee to get outside opinions about this. We think it’s very important for transparency,” he said, adding that the FDA is the only regulatory agency in the world that has such public data vetting.

“But we’ll make that decision. Our scientific experts will make that decision,” Hahn said.

8:23 a.m. ET, December 10, 2020

UK travelers could be banned from EU after January 1 under Covid-19 rules

From CNN's James Frater in Brussels

A passenger walks through Gatwick Airport in London, England, on November 27.
A passenger walks through Gatwick Airport in London, England, on November 27. Leon Neal/Getty Images

Travelers from the UK will from January be subject to the same travel restrictions as all other non-EU countries, which bar all but essential travel to Europe, a European official told CNN.

The current Brexit transition period ends on December 31 and these travel restrictions will still apply even if the UK and European Union strike a trade deal.

“The UK is not part of the Schengen area and -- following the end of the transition period -- it will also no longer be treated similarly to a Member State,” the official from the European Commission said, adding that the UK “will be subject to the [EU] Council Recommendation on the external travel restriction.”

The criteria in the recommendation is primarily based on whether a particular country’s epidemiological situation is better or lower than the EU average.

It also includes factors such as “containment measures, including physical distancing, as well as economic and social considerations.” 

Reciprocal arrangements on whether EU citizens are allowed to travel to that country, “should also be taken into account regularly and on a case-by-case basis,” the recommendation says. 

In October, EU member states decided that only eight countries met the "safe country" criteria, including Australia, Japan and New Zealand.

“The Council is responsible for reviewing the list of third countries towards which the travel restriction is lifted and the Council will therefore need to consider the inclusion of the UK,” said the Commission official.

What happens next: The UK will be considered with other non-EU countries at the next review scheduled to take place in the week of December 14, an EU official at the European Council told CNN. 

“The list of countries for which restrictions should be lifted is reviewed and, as the case may be, updated regularly,” the Council official explained, but said it was too early to “confirm at this stage what the status of a country will be on 1 January.”

Essential travel is categorized into 11 areas including:

  • healthcare professionals
  • passengers in transit
  • diplomats
  • people travelling for imperative family reasons.
8:30 a.m. ET, December 10, 2020

Pfizer principal investigator "very optimistic" about positive news after FDA meeting

From CNN Health’s Naomi Thoma

Dr. Onyema Ogbuagu, an associate professor at the Yale School of Medicine, and the principal investigator of the Pfizer trial there, said on Thursday that he is very optimistic there will be good news after the US Food and Drug Administration meeting. 

An FDA advisory committee is meeting on Thursday to discuss emergency use authorization for the Pfizer vaccine.

When asked by CNN’s Alisyn Camerota whether there was any reason or anything he had seen happen that would mean emergency use authorization wouldn’t happen, Ogbuagu said:

“No, I think there’s no reason to think that we won’t get a positive vote from the committee that sits today. We know that Canada and the UK have already done so.”

He said he knew Camerota was probably alluding to the reports of anaphylactic reactions in two individuals in the UK, but said to remember these were individuals with known histories of anaphylaxis, who carried EpiPens.

“I do hope at some point we can figure out which components of the vaccine led to that, but I really am very optimistic that we’ll have positive news after the meeting,” Ogbuagu said.


7:59 a.m. ET, December 10, 2020

CDC now projects up to 362,000 US Covid-19 deaths by January 2

From CNN Health’s Ben Tinker

A forecast published Wednesday by the US Centers for Disease Control and Prevention projects there will be 332,000 to 362,000 coronavirus deaths in the United States by January 2. 

Unlike some individual models, the CDC’s ensemble forecast only offers projections a few weeks into the future. The previous ensemble forecast, published December 3, projected up to 329,000 coronavirus deaths by December 26.

At least 289,450 people have already died from Covid-19 in the United States, according to data compiled by Johns Hopkins University.

CNN is tracking the spread of Covid-19 in the US here:

7:52 a.m. ET, December 10, 2020

China flight attendants advised to wear diapers for Covid protection

From CNN's Lilit Marcus

Transportation officials around the world have been looking for ways to keep passengers and crew safe on planes during the pandemic.

On November 25, the Civil Aviation Administration of China (CAAC) released new guidelines for the country's airline industry, which it oversees.

The document, titled Technical Guidelines for Epidemic Prevention and Control for Airlines, Sixth Edition, contains advice about the best hygiene practices to carry out on aircraft and in airports. 

But one of those suggestions -- that personnel like flight attendants wear disposable diapers so they don't need to use the bathroom -- has raised some eyebrows.

A section on PPE advises cabin crew on flights to and from high-risk countries to wear "medical masks, double-layer disposable medical gloves, goggles, disposable hats, disposable protective clothing, and disposable shoe covers."

The next sentence reads: "It is recommended that cabin crew members wear disposable diapers and avoid using the lavatories barring special circumstances to avoid infection risks."

While such advice may seem dramatic, it's no secret that lavatories can be the germiest place on an airplane. In August, a woman traveling from Italy to South Korea contracted coronavirus during her trip, and a visit to the bathroom -- the only place where she didn't wear an N95 mask -- was named as the possible source of her infection.

Read the full story here:

7:15 a.m. ET, December 10, 2020

Indian regulators request more data before approving AstraZeneca’s Covid-19 vaccine

From journalist Manveena Suri and Esha Mitra in New Delhi

Vials of AstraZeneca’s Covid-19 vaccine are seen inside a visual inspection machine at the Serum Institute of India on November 30.
Vials of AstraZeneca’s Covid-19 vaccine are seen inside a visual inspection machine at the Serum Institute of India on November 30. Francis Mascarenhas/Reuters

India’s Central Drugs Standard Organization (CDSCO) requested more data from the Serum Institute of India (SII), which applied for emergency use of AstraZeneca’s Covid vaccine on Monday. 

The CDSCO said on Thursday that SII should submit “updated safety data of Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of UK- MHRA (the UK’s Medicines and Healthcare products Regulatory Agency) for grant of EUA.”

The document read that SII firm presented their application “with the interim safety data from Phase II/III clinical trial carried out in the country and the interim safety and efficacy results of Phase II/III and Phase III clinical trials carried out in the UK, other countries and India.”

The regulator tasked with reviewing the emergency authorization application from SII met on Wednesday.

CNN has reached out to the Serum Institute of India. 

The background: The AstraZeneca/Oxford 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 yesterday.

But experts have raised questions after AstraZeneca's data showed the vaccine was about 62% effective in most people but 90% effective in a subset of volunteers who had a low first dose of vaccine.

Moncef Slaoui, chief adviser to Operation Warp Speed, told a news briefing Wednesday that the US Food and Drug Administration may prefer data generated from an ongoing US trial when it comes time to decide on authorizing the vaccine.