The latest on the Covid-19 pandemic and vaccines

A vial of remdesivir

Gilead Sciences said Wednesday that its late-stage trial of a three-day intravenous course of the antiviral remdesivir significantly reduced the risk of non-hospitalized Covid-19 patients becoming sicker and dying.

In this trial, remdesivir, also known by its brand name, Veklury, was tested on 562 people considered high-risk for severe Covid-19 based on their health conditions and age. Half received the drug and the other half received a placebo.

The group that got the drug saw an 87% reduction in risk of hospitalization by day 28, and an 81% reduced risk of dying compared with the group that got a placebo.

The company had stopped enrolling people in the trial in April, it said, “reflecting the evolution of the Covid-19 landscape and changing patient needs.” At that time, the National Institute of Allergy and Infectious Diseases had decided to start giving remdesivir to patients who had been receiving standard care, since NIAID found that the drug had showed a small effect against Covid-19. The company said it continued to collect data on the patients in its trial so that it was able to produce the results of this latest trial. 

The data has not yet been peer-reviewed or published, and Gilead said it will be presented at the IDWeek 2021 virtual conference.

What’s next: Gilead said it plans to continue to study how safe the drug is and how well it works in patients who are hospitalized. In November, the World Health Organization had updated its ongoing guidance on medication to advise against using the antiviral drug to treat hospitalized patients. However, it is approved for temporary use in 50 countries and has been provided to 127 middle and low income countries.

In October, the antiviral was the first drug to be approved by the US Food and Drug Administration to treat Covid-19; it’s approved for treatment of hospitalized adult and pediatric patients age 12 and older, and has emergency use authorization for treatment of younger children. It is approved for use only in a hospital or health care setting and needs to be administered by IV over 30 to 120 minutes.

Regular Covid-19 testing of all students and staff in schools catches cases that symptom-based testing may miss, according to research published Wednesday in the journal JAMA Network Open. 

As many as 9 in 10 cases among students and 7 in 10 cases among staff may be missed by conventional reporting mechanisms, the researchers said.

For the study, students and staff in three schools in Omaha, Nebraska, participated in a weekly PCR-testing program between November 9 and December 11, 2020. Over the study period, 2,885 self-collected saliva samples from 458 staff and 315 students with no symptoms were tested. Among those, 22 students and 24 students tested positive.

That’s around twice as many cases identified through symptom-based testing strategies, the researchers noted. The case rate was 7% among students and 5.3% among staff in the weekly testing program, compared to 1.2% among students and 2.1% among staff using conventional reporting mechanisms. Cases detected even exceeded the infection rates reported at the county level.

Covid-19 was also detected in wastewater samples from all three schools and air samples from two choir rooms. Researchers said this could be a cost-effective strategy to identify hot spots and guide where to direct individual screening, which is more resource-intensive.

Students in choir were 2.8 times as likely to test positive for the coronavirus than other students, when adjusting for school attended, but researchers note the impact of choir was not statistically significant.

The category of staffer was not significantly associated with coronavirus testing results, the authors said, but business teachers were 28.5% as likely to test positive than other staff members. “Our initial findings regarding business teachers suggest a higher risk for infection among teachers associated with computer laboratories,” the authors wrote.

The researchers said that the differences in community case rates and those among students and staff in the weekly testing program suggest that the strategy may help mitigate school-based transmission risk.

Paramedics prepare to transport a Covid-19 patient to a hospital in Houston, Texas, on September 15.

For the second consecutive week, an ensemble forecast from the US Centers for Disease Control and Prevention predicts that new daily Covid-19 hospitalizations will likely decrease over the next four weeks.  

Last week’s forecast, published Sept. 15, predicted hospitalizations would decrease for the first time since the June 23 forecast. 

This week’s forecast predicts that there will be 4,600 to 11,800 new confirmed Covid-19 hospital admissions likely reported on Oct. 18.

According to data from the US Department of Health and Human Services, there were 89,266 people hospitalized with Covid-19 as of Sept. 21. 

The new deaths forecast predicts that deaths will have a stable or uncertain trend over the next four weeks, with a total of 709,000 to 736,000 Covid-19 deaths reported by Oct. 16.

The previous weeks forecast predicted up to 719,000 deaths by Oct. 9

According to data from Johns Hopkins University, there have been 678,522 Covid-19 deaths in the United States. 

The cases forecast predicts 360,000 to 1,290,000 new cases likely reported in the week ending October 16. 

The agency did not forecast whether cases would increase in the next four weeks, something which has not been included since July 28. 

“Case forecasts were not assessed for likely increases or decreases because more reported cases than expected have fallen outside the forecast prediction intervals,” the forecast said.

The CDC headquarters in Atlanta, Georgia.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is meeting now, and the committee will hear presentations on Covid-19 vaccine booster doses from CDC experts and Pfizer, as well as presentation on vaccine effectiveness and vaccine safety during pregnancy.

They are scheduled to meet today until 4:30 p.m. ET and tomorrow from noon to 3:30 p.m. ET.

No vote is currently on the agenda today or tomorrow.

The US Food and Drug Administration is still considering a booster dose of the Pfizer/BioNTech Covid-19 vaccine after a lengthy discussion among its advisers on Friday.

If the FDA authorizes booster doses of Pfizer’s vaccine ahead of tomorrow’s ACIP meeting, the CDC committee could vote on whether to recommend the doses for use.

The United States is set to significantly increase the amount of Covid-19 vaccines it will ship to foreign nations beginning in 2022 in an effort to end the pandemic worldwide, the White House announced Wednesday.

As part of today’s virtual Covid-19 summit on the margins of the UN General Assembly, President Biden will announce that the US is purchasing an additional 500 million Pfizer Covid-19 vaccines to donate to low- and lower-middle-income countries around the world, a senior administration official said, previewing the summit. The newly announced 500 million doses are on top of the 500 million the US had already committed to sharing with other nations.

Those vaccines will begin shipping out in January, and from January through September of next year, the US will ship out 800 million vaccines to the world, the official said. These vaccines bring the United States total to over 1.1 billion vaccines donated to other countries.

The official said that the additional 500 million vaccines will be purchased at a not-for-profit price and will be distributed through Covid-19 Vaccines Global Access, the global vaccination program known as COVAX.

“We’re proving that you can take care of your own, while helping others as well. We can and we must do both,” the official said.

Read more about today’s Covid-19 summit here.

President Joe Biden addresses the United Nations General Assembly on September 21.

US President Biden called for a new era of international cooperation to fight the pandemic in his debut address to the United Nations General Assembly, but, one year after world leaders pledged to bring Covid-19 vaccines and treatments to “all people, everywhere,” the message of unity rang empty. 

Speaking to a much smaller crowd than usual due to the ongoing coronavirus crisis, Biden on Tuesday urged heads of state to take swift action to rein in a pandemic that has killed millions and continues to resurge. 

On Wednesday, the White House said it was set to send an additional 500 million doses of Covid-19 vaccines to foreign nations in 2022.  

But the ongoing debate over how best to address the wide gap in vaccine access is boiling over at the UN, with national leaders condemning vaccine abundance in rich nations like the US and the drip-feed of shots afforded to the rest of the world. 

President Rodrigo Duterte of the Philippines on Tuesday accused rich countries of hoarding Covid vaccines while the poor “wait for trickles” and developing countries consider half-doses to cover more of their populations. The Philippines has one of the lowest Covid vaccination rates in Asia, with just 17% fully vaccinated. 

The divide, Duterte said in a prerecorded speech, “is shocking beyond belief – it must be condemned for what it is, a selfish act that can neither be justified rationally nor morally.” 

Speaking to CNN on Sunday, UN Secretary-General Antonio Guterres highlighted Biden’s Covid-19 summit on the UNGA sidelines and an International Monetary Fund proposal to create a $50 billion vaccine program for poor countries, saying these were “positive signs” that rich nations were starting to work together to tackle vaccine inequity. 

Out of six billion doses administered worldwide, only 2% have been in low-income countries. Discussions around how many traveling diplomats might still be unvaccinated illustrated just “how dramatic” the disparity in distribution remains, Guterres told Reuters. In a new take on vaccine diplomacy, a free Covid-19 testing and vaccination van welcomed world leaders and delegates at the UN, with the aim of avoiding a super-spreader event. 

A so-called “honor system” calling for foreign delegations to be vaccinated before entering the assembly hall was broken on the very first day of the General Assembly. 

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is holding a two-day meeting on Wednesday and Thursday on booster shots.

Wednesday’s meeting will include a discussion on booster doses of Pfizer’s Covid-19 vaccine, vaccine effectiveness in the US and vaccine safety in pregnant women.

Wednesday’s meeting comes after the vaccine advisers to the US Food and Drug Administration voted Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine to people 65 and older and those at high risk of severe Covid-19 six months after they get their first two shots.

But the FDA’s Vaccines and Related Biological Products Advisory Committee rejected a broader application to approve booster doses of Pfizer’s vaccines for everyone 16 and older six months after they are fully vaccinated.

Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long term efficacy of a booster dose.

Biden administration officials had previously announced a plan to begin administering booster doses to the general population during the week of Sept. 20, irritating some members of the committee. They later noted that any action would be pending signoff from the FDA and the CDC.

The CDC must give its stamp of approval for any booster doses to be officially given. In a letter sent last Thursday and obtained by CNN, the CDC urged local and state health officials to wait to administer boosters until both agencies had signed off.

Third doses are already approved for certain immunocompromised people, but not for the general public.

The US Food and Drug Administration (FDA) could soon authorize a Pfizer/BioNTech Covid-19 vaccine for young children, experts said — a development that offers hope in the midst of a dangerous time in the pandemic for kids, who account for a quarter of all cases reported last week.

That process is happening as the second highest total of new cases in children was reported last week and cases among that group continue to rise exponentially, according to data from the American Academy of Pediatrics published Monday.

And as cases spread, hospitalization rates are high. An average of 311 children were hospitalized with Covid-19 every day over the past week, according to data from the US Centers for Disease Control and Prevention (CDC).

In Pittsburgh, officials at UPMC Children’s Hospital said they are seeing a “historic” number of children coming to the Emergency Department. A tent was set up outside the emergency room Friday to help accommodate more patients, the hospital said in a social media post.

Currently, the youngest Americans eligible for vaccination are 12 year olds, and the vaccination rate of adolescents is still inching toward the halfway mark, according to a CNN analysis of data from the CDC.

Where things stand now: Trials are currently underway for younger children, and Pfizer/BioNTech announced in a news release Monday that a Phase 2 of 3 trial showed their two-dose vaccine was safe and generated a “robust” antibody response in children 5 to 11.

The expansion of vaccine access would be important both for protecting children and for ending the hold the virus has on the US for everyone, dean of the National School of Tropical Medicine at Baylor College of Medicine, Dr. Peter Hotez said.

“Ultimately, if we’re serious about halting this epidemic in the United States, we need 85-90% of the US population vaccinated,” Hotez said. “That means all of the adults, all of the adolescents and large numbers of young kids.”

But there is still a big challenge ahead: getting the doses into kid’s arms, CNN medical analyst Dr. Johnathan Reiner said.

The Covid-19 pandemic was a central focus of President Biden’s speech yesterday before the United Nations General Assembly.

Biden argued that the global community’s response to pressing challenges like the climate crisis and the Covid-19 pandemic will “reverberate for generations yet to come.”

Biden touted the US shipping more than 160 million Covid-19 doses to countries around the world and putting more than $15 billion toward the global pandemic response

“Planes carrying vaccines from the United States have already landed in 100 countries, bringing people all over the world a little dose of hope as one American nurse termed it to me. A dose of hope, direct from the American people, and importantly, no strings attached,” the President said.

Biden said that he’d be announcing additional commitments at a US-hosted virtual global Covid-19 summit today as the country “seeks to advance” the fight against Covid-19 and “hold ourselves accountable around specific targets on three key challenges.”

Biden listed those challenges as:

CNN’s Kate Sullivan, Maegan Vazquez and Kevin Liptak contributed reporting to this post.