US FDA panel recommends Covid-19 vaccine authorization

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 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.

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.

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.

“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.

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.

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 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.

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:

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:

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.

WATCH:

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:

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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."

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:

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China flight attendants advised to wear diapers for Covid protection

By Lilit Marcus, CNN

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.