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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9:30 a.m. ET, December 10, 2020

“It’s a really important day for all of America,” FDA commissioner says

From CNN's Naomi Thomas

Dr. Stephen Hahn, US Food and Drug Administration commissioner, attends a hearing on June 30 in Washington, DC. Al Drago/Pool/Getty Images

“It’s a really important day for all of America,” US Food and Drug Administration Commissioner Dr. Stephen Hahn told NBC’s Savannah Guthrie Thursday as the FDA’s Vaccines and Related Biological Products Advisory Committee meets to discuss emergency authorization of Pfizer’s Covid-19 vaccines.

“It’s an emotional one, obviously, because the country has been through so much in this pandemic,” Hahn said. “It’s affected so many lives in devastating ways.”

Thinking about how to get beyond the pandemic, Hahn said that a vaccine will be “the primary way in terms of stopping the spread beyond the mitigation efforts we need right now.”

“So if, in fact, there is an authorization and we begin vaccinating, a national vaccine campaign, there is great hope, great light for this country and I think we all look forward to getting beyond this and having a more normal and healthy life,” Hahn said.

More on today's meeting: The advisory committee is expected to vote on a recommendation to the FDA on an emergency use authorization this afternoon. The vote doesn't mean the vaccine is authorized immediately. The decision comes from the FDA, which typically follows the advisory committee's recommendation.

9:28 a.m. ET, December 10, 2020

The FDA's advisory committee meeting on Pfizer's vaccine has begun. Here's how today's key event will unfold.

From CNN's Maggie Fox

The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee is meeting now to discuss emergency use authorization for Pfizer and BioNTech's coronavirus vaccine.

The EUA is widely expected, but the FDA has promised to listen to the advice of the panel.

“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,” FDA Commissioner Dr. Stephen Hahn said Thursday.

The panel is expected to vote on a recommendation to the FDA on an emergency use authorization this afternoon.

Remember: The vote doesn't mean the vaccine is authorized immediately. The decision comes from the FDA, which typically follows the advisory committee's recommendation.

Here's a look at how today's meeting is expected to unfold:

Staff at the FDA's Office of Vaccines Research and Review will run down the FDA's study of Pfizer's data.
Dr. Nancy Messonnier, who heads the US Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases, will review the CDC's plans for safety monitoring and other CDC officials will update on the pandemic itself and plans for distributing the vaccine.
Stanford University's Dr. Steven Goodman will talk about what it means for clinical trials going forward if a vaccine is approved. He'll address the question of asking people to forgo getting a vaccine known to be protective in order to test an unproven one. Pfizer will also present its data.
The committee is expected to vote this afternoon on whether to recommend authorization.

Saudi Arabia registers Pfizer/BioNTech vaccine for import and local use

From CNN’s Gul Tuysuz and Mostafa Salem

Just days after the United Kingdom became the world's first nation to begin vaccinating its citizens with a fully vetted and authorized Covid-19 shot, health authorities in Saudi Arabia have approved the registration of the Pfizer/BioNTech coronavirus vaccine for import and use, state news agency SPA said Thursday.

According to SPA, data from Pfizer was submitted to Saudi Arabia’s Food and Drug Authority in November, detailing the efficacy and safety of the vaccine. The data was then studied by authorities in Saudi Arabia before being approved for use, the statement added.

Watershed moment: Saudi Arabia’s decision comes a week after Bahrain announced it would become the second country in the world after the UK to approve the Pfizer/BioNtech vaccine for emergency use authorization.

According to the Johns Hopkins University tally of cases, Saudi Arabia has recorded 359,274 coronavirus cases and 6,002 deaths since the beginning of the pandemic.

9:13 a.m. ET, December 10, 2020

A key FDA panel meets at 9 a.m. ET to discuss authorizing Pfizer's vaccine. Here's what you need to know.

From CNN's Maggie Fox

A health worker in Hollywood, Florida, injects a person during clinical trials for a Pfizer coronavirus vaccine on September 9. Eva Marie Uzcategui/Bloomberg/Getty Images

There's not much suspense going into Thursday's meeting of the US Food and Drug Administration's vaccine advisers, who will discuss emergency use authorization for Pfizer and BioNTech's coronavirus vaccine. The meeting will be held from 9 a.m. ET to 6 p.m. ET.

The EUA is widely expected and has been telegraphed with unusual frankness from the top of the FDA on down. But, the FDA has promised to listen to the advice of its Vaccines and Related Biological Products Advisory Committee.

Here are key things to know about today's meeting:

Who is on the panel? The Vaccines and Related Biological Products Advisory Committee is made up of independent vaccine experts, infectious disease specialists, industry representatives and a consumer representative — 17 regular members and 13 temporary voting members.
What is expected to happen today? The panel is expected to vote on a recommendation to the FDA on an emergency use authorization for Pfizer’s Covid-19 vaccine. The vote doesn't mean the vaccine is authorized immediately. The decision comes from the FDA, which typically follows the advisory committee's recommendation.
What main points will they consider? The only real questions will be about whether the advisers recommend restrictions to the EUA — perhaps leaving children off the lIst for now, for example. They'll also discuss how to conduct the post-EUA safety surveillance and whether to offer the shot to clinical trial volunteers who got placebo doses.
What comes next? The FDA will then decide on whether or not to issue an emergency use authorization for the vaccine. The FDA EUA allows shipping to begin, but shots still can’t be administered until the CDC advisory committee recommends the vaccine. In anticipation of an EUA, the CDC's Advisory Committee on Immunization Practices has scheduled emergency meetings for Friday and Sunday. This committee — which is separate from FDA's advisory committee — will recommend whether the CDC should offer the vaccine to the American public. After the CDC accepts that recommendation, Pfizer shots may start to be administered.

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

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. 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. 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.