Pfizer's Covid-19 pill is a treatment, not a preventative measure, official says

The latest on the coronavirus pandemic and the Omicron variant

By Ed Upright, Aditi Sangal, Adrienne Vogt and Meg Wagner, CNN

Updated 1048 GMT (1848 HKT) December 15, 2021
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10:46 a.m. ET, December 14, 2021

Pfizer's Covid-19 pill is a treatment, not a preventative measure, official says

From CNN's Naomi Thomas

Pfizer CEO Albert Bourla delivers a speech in Thessaloniki, Greece, on October 12.
Pfizer CEO Albert Bourla delivers a speech in Thessaloniki, Greece, on October 12. (Sakis Mitrolidis/AFP/Getty Images)

Pfizer Chair and CEO Albert Bourla said that the company’s antiviral pill is a Covid-19 treatment, not prevention, and people still need to get vaccinated.

“This is a treatment, this is not something that we use for prevention at this stage,” Bourla said, when asked on CBS Mornings on Tuesday about how the pill could be a gamechanger for dealing with Covid-19.

“People that are getting sick, unfortunately some of them ending up in hospitals or ending up dying. With this pill, we have now proof that instead of 10 of them going to hospital, only one will go and, frankly, no one died in this study," he said.

Mortality should be prevented at very high levels, he said. 

“It’s a game changer,” he said. 

Asked if the news about the treatment would encourage those who haven’t been vaccinated to think that they don’t need to be, Bourla said, “there is a risk to happen, what you said, and that will be a very big mistake. Vaccines are needed, people need to prevent getting sick. They should not take chances that they may not get seriously sick because there’s a pill that could treat them. People should prevent.” 

People need to get vaccinated to protect themselves and those that they love, he said. 

“But, unfortunately, there will be cases of Covid disease,” he said. “And now, this is the big news, when we have Covid surges, usually what is happening is that our hospitals are overwhelmed, people are in ICUs, hospitals need to change the normal procedure, sometimes they postpone elective surgeries. It’s a very big problem for the health care system. Right now, with this pill, instead of 10 going there, only one, nine will stay at home and hopefully nobody will die. This is a very big deal.” 

8:25 a.m. ET, December 14, 2021

Vaccines are not being wasted in Africa, WHO official says

From CNN’s Vasco Cotovio

The World Health Organization’s regional office for Africa says it is necessary to “dispel” the notion that vaccines are being wasted in Africa, explaining less than 0.25% of doses made available to the continent have expired. 

“It’s necessary to dispel the impression that, even as we are expressing concerns over access to vaccine supplies, that there are millions of doses being wasted and expiring in Africa,” WHO’s regional director for Africa, Dr. Matshidiso Moeti, told journalists during a virtual news conference on Tuesday. 

“That is not the case,” she added.

Moeti went on to break down the number of vaccines received, administered and the ones which have expired in Africa.

“We have had about 434 million doses received in Africa, about 264 million doses administered in Africa, about 61% of those that have been received and 910,000 vaccines have expired in 20 countries,” she said. “That represents less 0.25% of the doses that have been received in Africa.”

Moeti explained that the main challenge in Africa continues to be “access to vaccine supplies,” but conceded that the planning operation for vaccine delivery in the continent, which has been largely dependent on donations of a wide variety of vaccines, had also been a factor. 

“Planning for the operation of vaccine delivery has been extremely challenging for African countries,” she said. “There is a great deal of concern now about ensuring that the vaccines that are being delivered in African countries have an adequate shelf life to enable the delivery operation to be undertaken in such a way that we minimize the expiry of vaccines and what might be considered the waste of vaccines.”

10:35 a.m. ET, December 14, 2021

Science around definition of fully vaccinated still evolving, CDC director says  

From CNN Health’s Naomi Thomas

Dr. Twana Jackson prepares a Covid-19 vaccine in Freeport, New York, on November 30.
Dr. Twana Jackson prepares a Covid-19 vaccine in Freeport, New York, on November 30. (Steve Pfost/Newsday RM/Getty Images)

The science around whether the definition of "fully vaccinated" should change from two shots to three shots is still evolving, Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention (CDC), said on NBC’s Today on Tuesday.

“What we know about variants is that the more mutations you have, the more immune boost you need in order to combat them, so that’s exactly why we’re saying this variant has a lot of mutations, we want to make sure that we have as much immune protection as possible,” Walensky said, when asked if the definition of fully vaccinated should be changed to include a booster shot. 

She urged people to get the vaccine if they hadn't yet, and if eligible for a booster shot, to "get that boost because you’ll have more protection."

Asked again if fully vaccinated should be two or three doses, Walensky said that the science is evolving right now: “As that science evolves, we will continue to follow it for that question,” she said.

7:49 a.m. ET, December 14, 2021

Pfizer: Final data on pills to treat Covid-19 holds strong against hospitalization and death

From CNN Health’s Michael Nedelman

Pfizer’s Covid-19 pill, Paxlovid, is manufactured in Ascoli, Italy.
Pfizer’s Covid-19 pill, Paxlovid, is manufactured in Ascoli, Italy. (Pfizer/Handout/Reuters)

Pfizer's updated results for its experimental treatment for Covid-19 showed it cut the risk of hospitalization or death by 89% if given to high-risk adults within a few days of their first symptoms, the company announced in a news release Tuesday.

Pfizer hopes it can eventually offer the pills, under the name Paxlovid, for people to take at home before they get sick enough to go to the hospital. Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir.

After a month of follow-up, the study found five hospitalizations and no deaths among 697 people who received the drug within the first three days of symptoms. Among 682 who received placebo, 44 were hospitalized, including 9 who died. All of the adults in this study were unvaccinated.

If given within the first five days of symptoms, the efficacy was similar: 88%. These results hold up against a similar announcement from the company last month, when not all the data had come in yet.

The research also showed "an approximate 10-fold decrease in viral load at Day 5, relative to placebo," the statement said.

"This underscores the treatment candidate's potential to save the lives of patients around the world, whether they have been vaccinated or not," Pfizer CEO Dr. Albert Bourla said in a statement Tuesday. "Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic."

The company says it expects the drug to retain activity against variants like Omicron -- and it appears to do so in lab tests -- because the drug blocks an enzyme involved in viral replication. This is different from the spike protein on the virus' surface, whose numerous mutations have escalated the global concern around the variant.

Pfizer added that full study data are expected to be released later this month and submitted to a peer-reviewed publication.

7:18 a.m. ET, December 14, 2021

France's Covid rules aren't expected to change despite surging cases

From Dalal Mawad in Paris

France does not “expect” to introduce new restrictions despite a recent rise in cases attributed to the Omicron variant, said French government spokesman Gabriel Attal.

“We have reinforced the restrictions at the border,” Attal told French radio Franceinfo on Tuesday. “In France, rules are not expected to change.”

Attal said there are currently 133 diagnosed Omicron cases but he admits that more may have gone undetected.

“We are certain that there are probably more cases than those which are sequenced, the 133 that I mentioned,” Attal said, adding that French health authorities were screening and then sequencing "a lot" of those positive Covid-19 cases detected in the country, but that the process takes time.

More than 10,000 cases have been sequenced per week, according Attal, who went on to say there is “strong concern” over the new variant.

“It seems established by now that it is even more contagious than the Delta variant,” he said, adding that the country is hoping booster vaccinations will be enough to contain its spread. “We had a policy in France which attempted to delay the arrival of this variant on our territory as much as possible until the booster vaccination campaign kicked off.”

 

6:56 a.m. ET, December 14, 2021

Omicron variant found in at least 32 states

Test tubes hold Covid-19 tests in Los Angeles, California, on December 6.
Test tubes hold Covid-19 tests in Los Angeles, California, on December 6. (Allison Zaucha/Bloomberg/Getty Images)

The Omicron variant has been identified in at least 32 states on Monday.

Here's the full list:

  • Alaska
  • Arizona
  • California
  • Colorado
  • Connecticut
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Iowa
  • Louisiana 
  • Maryland
  • Massachusetts
  • Michigan 
  • Minnesota
  • Mississippi
  • Missouri
  • Nebraska
  • New Hampshire
  • New Jersey
  • New York
  • North Carolina 
  • Ohio
  • Oregon
  • Pennsylvania 
  • Rhode Island
  • Texas
  • Utah
  • Virginia 
  • Washington
  • Wisconsin

6:11 a.m. ET, December 14, 2021

Emma Raducanu tests positive for Covid-19

From Reuters

Emma Raducanu competes in the Transylvania Open in Cluj-Napoca, Romania, on October 29.
Emma Raducanu competes in the Transylvania Open in Cluj-Napoca, Romania, on October 29. (Flaviu Buboi/NurPhoto via Getty Images)

US Open champion Emma Raducanu has tested positive for COVID-19 and will miss this week's Mubadala World Tennis Championship exhibition event in Abu Dhabi, the 19-year-old Briton said on Monday.

Raducanu, who became the first qualifier to win a major when she triumphed at Flushing Meadows in September, was due to face Olympics singles gold medallist Belinda Bencic at the December 16-18 event.

"I was very much looking forward to playing in front of the fans here in Abu Dhabi, but unfortunately after testing positive for Covid-19, I will have to postpone until the next opportunity," Raducanu said.

"I'm isolating as per rules and hopefully will be able to get back soon."

Read more here.

6:01 a.m. ET, December 14, 2021

Spain to begin vaccinating children aged 5 to 11 on Wednesday

From CNN's Al Goodman in Madrid

A health worker prepares a Covid-19 vaccine at Isabel Zendal Hospital in Madrid, Spain, on November 26.
A health worker prepares a Covid-19 vaccine at Isabel Zendal Hospital in Madrid, Spain, on November 26. (Burak Akbulut/Anadolu Agency/Getty Images)

Spain will begin vaccinating children aged 5 to 11 on Wednesday, the Health Ministry has announced. 

The aim is to vaccinate the 3.3 million children in this age range during December and January, according to a Health Ministry statement. 

The Health Ministry sent the first shipment of 1.3 million doses to Spain's 17 regions this week and more doses are due in January, the statement added.

It comes after the country's public health commission approved the Covid-19 vaccination for 5 to 11-year-olds on December 7.

Spain has fully vaccinated 89.6% of its population 12 years and older, per the Health Ministry's latest data, issued on Monday

5:52 a.m. ET, December 14, 2021

South African study indicates people less likely to be hospitalized with Omicron variant

From CNN Health’s Maggie Fox

A new study from South Africa indicates that Pfizer/BioNTech’s vaccine is only about 33% effective against the Omicron variant of coronavirus, but people infected with the Omicron variant are less likely to end up in the hospital than those infected with the original strain of the virus.

The data comes from Discovery Health, a large health insurance company that covers 3.7 million people in South Africa. The team there, along with researchers at the South African Medical Research Council, looked at claims data coming from the time when Omicron became predominant across South Africa, and compared it to data from earlier periods.

They examined 211,000 positive coronavirus test results, 41% of them taken from adult members who had been given two doses of Pfizer’s vaccine. The company estimated 78,000 of these cases involved Omicron between November 15 and the first week of December.

They estimate the risk of ending up in the hospital from Covid-19 was 29% lower for Omicron infections in adults, compared to the original virus, but said children were 20% more likely to be hospitalized. The comparison was to one of the first strains of the virus, not to the Alpha or Beta variants that were prevalent in South Africa this year.

Two doses of the Pfizer vaccine was 33% protective against infection overall, but 70% effective in preventing severe complications including hospitalization, they said. 

“The Omicron-driven fourth has a significantly steeper trajectory of new infections relative to prior waves. National data show an exponential increase in both new infections and test positivity rates during the first three weeks of this wave, indicating a highly transmissible variant with rapid community spread of infection,” Dr. Ryan Noach, CEO of Discovery Health, said in a statement.

“Overall, the risk of re-infection following prior infection has increased over time, with Omicron resulting in significantly higher rates of reinfection compared to prior variants,” Shirley Collie, chief health analytics actuary at Discovery Health, said in a statement. Collie said people in South Africa’s Delta wave had a 40% relative higher risk of reinfection with Omicron and those infected when Beta predominated had a 60% higher relative risk of reinfection with Omicron.

“Notwithstanding the fact that children continue to show a very low incidence of severe complications following Covid-19, Discovery Health’s data indicate that children under age 18 have 20% higher risk of admission for complications of Covid-19, when infected with Omicron,” Collie added.

“This is early data and requires careful follow up. However, this trend aligns with the South Africa’s National Institute for Communicable Diseases (NICD) warning in recent days that during South Africa’s third wave of infection (June to September 2021) they had seen an increase in pediatric admissions and now, in the fourth wave, they are seeing a similar increase in admissions for children under five. Anecdotal reports from hospitals in South Africa indicate that most Covid-19 diagnoses in children admitted to hospital are co-incidental -- many children that are admitted for non-COVID related conditions, and are not experiencing Covid-19 complications, test positive for Covid-19 on routine screening tests.”