After the President recently said the pandemic "is over," his chief medical advisor is pumping the brakes.
Plus, Americans have been slow on the uptake with updated booster shots, CDC data show.
And Ocugen is paying $1 million for regional rights to an intranasal COVID-19 vaccine.
Please read below for the latest updates. Daily COVID-19 tracker entries from April 14 to Aug. 31 can be found here.
UPDATED: Thursday, Oct. 6 at 10:50 a.m. ET
It would be “a bit cavalier” to say the pandemic has ended, NIAID director Anthony Fauci, M.D., said on a recent panel by the University of Southern California’s Annenberg Center for Health Journalism on COVID-19. “I don’t think we can say the end of COVID is in sight,” he said, as quoted by NJ Spotlight News. Fauci is also chief medical advisor to President Joseph Biden. His comments come shortly after Biden said the pandemic “is over” during a September interview.
Roughly one month after pharmacies and other vaccination sites started distributing updated boosters against COVID-19, CDC vaccination stats show less than 4% of the U.S. population of about 333.1 million people has received the latest shot. Specifically, the CDC says 7.6 million people have received a re-tooled booster dose, accounting for some 2.3% of the country’s population. Still, that number could be an underestimate, some local news outlets have reported, noting that the data omit people who received the updated Pfizer-BioNTech boosters in Idaho and Texas.
Ocugen is paying The Washington University an initial license issuance fee of $1 million to snag the rights to an intranasal COVID-19 vaccine in the U.S., Europe and Japan. The biotech is also in line to pay an annual license maintenance fee and regulatory and commercial milestones of up to $37 million. Story
UPDATED: Wednesday, Oct. 5 at 9:57 a.m. ET
After hearing feedback from the FDA, Eiger BioPharmaceuticals said it doesn't plan to seek an emergency use authorization for peginterferon lambda to treat mild-to-moderate COVID-19. Eiger's stock was down about 8% after the news on Wednesday.
Japan has approved Pfizer's updated vaccine targeting the BA.5 subvariant of omicron, Kyodo News reports. Additionally, regulators there blessed the company's original shot in kids 6 months to 4 years old.
In the U.S., an even newer variant, BA.4.6, now makes up around 13% of cases, according to new CDC data. The variant made up a bigger portion of cases—22%—in a region that includes Iowa, Kansas, Nebraska and Missouri.
UPDATED: Tuesday, Oct. 4 at 11:13 a.m. ET
Following Pfizer and Merck & Co., Shionogi has signed a volunatry license agreement, making its COVID antiviral candidate ensitrelvir (S-217622) available to qualified generic manufacturers through the Medicines Patent Pool. The goal is to expand access of the drug, pending regulatory authorizations, to low- and middle-income countries. The drug just succeeded in a phase 3 trial in Asia, showing it can significantly reduce the time to resolution of typical omicron-related symptoms.
The FDA has sent out an alert warning the public of reduced power by AstraZeneca's Evusheld at preventing COVID caused by certain coronavirus variants. But unlike other COVID antibodies for treating disease, Evusheld gets to keep its emergency use authorization as the only option for preventing COVID in immunocompromised people and individuals who aren't suitable to receive a COVID vaccine.
In a new editorial, The Lancet Respiratory Medicine argued that now is not the time to declare the pandemic over and to stop government-funded vaccination and treatment, "as this could discourage compliance with COVID-19 measures currently in place." The editorial team pointed to people who are uninsured, rising inflation and ongoing healthcare inequities as reasons to continue support the government's COVID funding.
The U.S. Supreme Court has declined to hear a challenge by 10 states to President Joe Biden's COVID vaccine mandate for healthcare workers at federally funded facilities, a rule that has been in place since November 2021, Reuters reports.
UPDATED: Monday, Oct. 3 at 10:26 a.m. ET
Moderna refused a request by officials in China to share its COVID-19 vaccine intellectual property, The Financial Times reports. Afterward, negotiations around a potential supply deal in China broke down. Moderna insists it is still interested in supplying vaccines to the country, according to the report.
Shortly after Europe published a report scrutinizing a large vaccine supply deal with Pfizer, the drugmaker's CEO Albert Bourla has pulled out of a special meeting to discuss the issue, Politico reports.
Roche launched a next-generation diagnostic in countries that accept the CE Mark authorization, Labiotech.eu reports. The new product is an update to the earlier version that launched in July 2020, and it's intended to be used in a wider range of patients.
UPDATED: Friday, Sept. 30 at 10:32 a.m. ET
Germany's InflaRx has submitted a request for emergency use authorization for vilobelimab to the FDA. The company is seeking an authorization for its drug to treat critically ill patients with COVID-19 after it had "encouraging interactions" with the agency.
Ahead of winter, bulk orders of coronavirus tests seem to be on the rise once again, Yahoo Finance reports. The CEO of iPromo, which sells two tests, told the publication that sales had surged recently compared with earlier summer months.
UPDATED: Thursday, Sept. 29 at 11:30 a.m. ET
Shionogi of Japan has reported positive results from a phase 3 trial of its COVID-19 oral antiviral Xocova. Among 1,821 mostly vaccinated patients who were infected within four days, the protease inhibitor resolved omicron symptoms by an average of 24 hours faster than placebo. Japan has agreed to buy 1 million doses of Xocova, pending its approval.
Ocugen will help develop, manufacture and commercialize a COVID nasal spray vaccine discovered by Washington University of St. Louis. Ocugen’s rights will extend to the US, Europe and Japan. The vaccine already has been approved in India.
The European Medicines Agency has accepted applications from Pfizer-BioNTech and Moderna for approval of their respective bivalent boosters formulated to defend against the BA.4 and BA.5 omicron subvariants. While Moderna’s application is for those 12 and older, Pfizer’s covers children ages 5-11.
Massachusetts-based VBI Vaccines has begun enrolling patients in a phase 1 trial of its multivalent enveloped virus-like particle (eVLP) coronavirus vaccine candidate designed to defend against all existing variants and subvariants of COVID-19.
After more than 430 emergency green lights for COVID-19 tests since the start of the pandemic, the FDA is beginning to wind down its expedited review programs for coronavirus diagnostics, instead urging developers to follow its traditional regulatory paths to market. Story
UPDATED: Wednesday, Sept. 28 at 8:47 a.m. ET
After CureVac recently sued vaccine giants Pfizer and BioNTech for alleged patent infringement, the mRNA partners are fighting back. In London court, the pair behind Comirnaty are seeking to invalidate two European CureVac patents, Law360 reports.
In a bid to expand the reach of its antiviral, Merck is partnering with Sinopharm for a rollout in China. Under the deal, Sinopharm will be responsible for producing and distributing Merck and Ridgeback's molnupiravir in China.
A study funded by the National Institutes of Health has linked COVID-19 vaccination with a small increase in menstrual cycle length. The study included data from more than 20,000 people and found that vaccines were associated with a menstrual cycle length increase of less than one day. The increase was usually temporary, researchers found.
UPDATED: Monday, Sept. 26 at 11:15 a.m. ET
Pfizer and BioNTech have completed their submission to the FDA for emergency use authorization of a 10- µg booster dose of their omicron BA.4/BA.5-adapted COVID-19 vaccine for children 5 through 11 years of age. The companies plan to finish an application in Europe in the ocming days. Meanwhile, a multiphase study is testing the safety, tolerability, and immunogenicity of different doses of the booster vaccine in children 6 months through 11 years of age.
Pfizer CEO Albert Bourla tested positive for COVID-19 over the weekend. It’s the second time he’s contracted the virus in as many months. The CEO said that he is “feeling well and symptom free,” Reuters reports. Bourla has received four doses of his company’s COVID-19 vaccine, but hasn’t yet taken the new bivalent booster, following CDC recommendations to wait three months since his previous COVID-19 case.
China has authorized another oral antiviral, made by Fujian Cosunter Pharmaceutical Co Ltd, for use in clinical trials, Global Times reports. The drug, called GST-HG171, will be used in trials for the treatment of mild-to-moderate COVID-19 in adults.
UPDATED: Friday, Sept. 23 at 10:05 a.m. ET
In the last two weeks, a new variant dubbed BF.7 has doubled in prevalence nationwide, representing 1.7% of total cases as of a recent CDC update. Right now, the variant is mostly concentrated in the Northeast United States. Fierce Healthcare story
Pfizer and U.S. officials have agreed to update a vaccine supply deal that focuses on shots bound for low- and middle-income countries. Responding to low demand and vaccine hesitancy in certain countries, the parties have agreed to slow deliveries, Bloomberg reports. The U.S. previously agreed to purchase the deals from Pfizer at a nonprofit price in order to donate them.
Several weeks after the U.S. authorized new, updated COVID-19 boosters from Pfizer and Moderna, millions of residents have opted to get the shots, Reuters reports. So far, more than 4 million have gotten the updated boosters.
UPDATED: Thursday, Sept. 22 at 11:20 a.m. ET
Pfizer will supply up to 6 million doses of its COVID-19 treatment Paxlovid to the NGO Fund for middle- and low-income countries. Aside from this effort, Pfizer also has made deals with generic drugmakers to produce the oral antiviral for poor countries.
A study from Epic Research shows that those who receive Pfizer’s Paxlovid are two times less likely to be hospitalized from COVID-19 and four times less likely to die than those who didn’t get the oral antiviral. The study included 567,560 patients diagnosed with COVID who were deemed to be high risk of advancing to a severe form of the virus. Additionally, fully vaccinated patients over age 50 who received Paxlovid were three times less likely to land in the hospital.
UPDATED: Wednesday, Sept. 21 at 11:15 a.m. ET
AstraZeneca is teaming up with The Dude and the duo behind The Big Sick to raise awareness of antibody treatments like the company's drug Evusheld for immunocompromised COVID patients. The British pharma’s “Up the Antibodies” campaign seeks to educate the public around the difficulties of living with an immunocompromised system and the available monoclonal antibody options to help the prevention of contracting COVID-19. Aside from actor Kumail Nanjiani and his wife and Hollywood writer Emily V. Gordon, the AZ campaign also features Jeff Bridges, Crystal King, who is a kidney transplant recipient, as well as transplant surgeon Dorry Segev, M.D., Ph.D. Story
COVID shot latecomer Clover Biopharmaceuticals is now pitching its first-gen adjuvanted protein vaccine as a “universal booster,” touting antibody levels against the omicron BA.5 subvariant to pad its case. In a phase 3 trial testing Clover’s shot as a booster against the original strain of SARS-CoV-2, Clover linked its prophylactic to fivefold higher neutralizing antibodies against the subvariant versus a third dose of its shot. Shanghai-based Clover aims to fill a different niche in the global vaccine market than Moderna and Pfizer but even so may struggle to make an impact. Story
Less than a month after Everest said its CEO Kerry Blanchard would disembark from the company, the Chinese drug developer has found a new leader in pharma veteran Rogers Yongqing Luo. Lou previously worked at Brii Biosciences as president and general manager for greater China. Further, Luo was CEO of Brii’s TSB Therapy unit, where he oversaw registration and commercialization of amubarvimab/romlusevimab, the first COVID-19 antibody regimen in that country. Story
Pulse oximeters—crucial for making treatment decisions during the COVID-19 pandemic—often yield inaccurate readings for people with darker skin tones, mounting evidence suggests. Now, the FDA has lined up a virtual meeting of its medical devices advisory committee to home in on the devices’ racial bias. Pulse oximeters are typically placed over the fingertip, where they emit light beams through the skin to assess a wearer’s pulse rate, plus the level of oxygen saturation in their blood. Story
UPDATED: Tuesday, Sept. 20 at 9:35 a.m. ET
Share prices for Moderna, BioNTech and Novavax all fell after President Joe Biden told 60 Minutes the pandemic "is over" on Sunday. The companies' share prices fell by as much as 9%, Yahoo! Money reports. As the publication notes, the U.S. is seeing an average of 60,000 new cases each day, with deaths averaging 500 daily.
After reporting a profit of £19.2 million in last year's first half, Oxford Biomedica has swung to a loss of £27.4 million in the first half of 2022, The Business Magazine reports. The company has been a key manufacturing partner for AstraZeneca, but the pharma giant's shot is seeing lower demand these days.
Even though Valneva was able to score a vaccine authorization in Europe, the shot has also suffered from low demand. Now the company has been forced to cut its manufacturing deal with IDT Biologika. Story
UPDATED: Monday, Sept. 19 at 9:15 a.m. ET
Speaking with Scott Pelley of 60 Minutes, President Joe Biden said he believes the pandemic is "over" but that COVID-19 is still a "problem." The comment came shortly after World Health Organization director-general Tedros Adhanom Ghebreyesus said the end of the pandemic was "in sight."
As part of a program by the World Health Organziation to advance a vaccine for low- and middle-income countries, Moderna allowed its vaccine to be studied as the comparison arm in a mouse study, Bloomberg reports. Pfizer rejected a similar request, the news service said. The World Health Organization has tapped Afrigen to develop a vaccine that, if successful, would be made at 15 production sites around the world.
UPDATED: Thursday, Sept. 15 at 9:30 a.m. ET
The European Court of Auditors wants to know how Europe secured its biggest vaccine deal—a 1.8 million-dose contract with Pfizer-BioNTech—but so far, the budget watchdog has been met with silence, according to a recent report. Despite request for details, “none was forthcoming,” the Court said in its report. The report also pressed European officials to again search for text messages between European Commission President Ursula von der Leyen and Pfizer CEO Albert Bourla. Story
Speaking of Pfizer and BioNTech, the companies’ South African partner Biovac has reportedly finished the first doses of the mRNA shot Comirnaty at its Cape Town manufacturing plant, according to Bloomberg. Before Biovac starts on its next production batch, the first set of shots will be evaluated by the South African Health Regulatory Products Authority, Morena Makhoana, Biovac’s CEO, said in an interview with the news outlet. Subsequent doses will be sold commercially starting next year. Story
“We are not there yet. But the end is in sight,” World Health Organization Director Tedros Adhanom Ghebreyesus said of the COVID-19 pandemic Wednesday, as quoted by Reuters. "Now is the time to run harder and make sure we cross the line and reap the rewards of all our hard work,” added the WHO chief. Looking ahead, countries should examine their policies and bolster them against COVID-19 and future health emergencies, he continued, according to Reuters. Ghebreyesus also urged countries to vaccinate 100% of their high-risk populations and continue COVID-19 testing efforts.
But it’s a different story in Africa, where the acting director of the continent’s Centers for Disease Control and Prevention warned Thursday that the “virus is still circulating.” Given low vaccination rates, “the pandemic is still very much with us here on the continent," Ahmed Ogwell Ouma said at a recent news conference. Ouma added that just over 22% of Africa’s population is fully vaccinated against COVID, noting that his agency will push to raise that number, according to Reuters.
UPDATED: Wednesday, Sept. 14 at 10:10 a.m. ET
Moderna's CEO Stéphane Bancel told Reuters the company has held conversations with the Chinese government about supplying its mRNA vaccine in the country, but that it's not immediately clear whether the sides will ink a deal. Additionally, Moderna believed its mRNA rival BioNTech infringed its patents early in the pandemic, the helmsman said.
More than half of U.S. adults plan to get a booster shot within the next year, a Morning Consult poll found. Further, 56% of adults plan to seek a booster dose each year.
Revive Therapeutics submitted an amended phase 3 study plan to the FDA. The company is studying bucillamine in patients with mild-to-moderate COVID-19. Revive says the drug is an oral medicine with anti-inflammatory and antiviral properties.
UPDATED: Monday, Sept. 12 at 11:20 a.m. ET
Europe has sanctioned use of Novavax’s COVID-19 vaccine as a booster regardless of previous vaccination history. The authorization of Nuvaxovid covers those 18 and older and comes nine months after Europe signed off on use of Novavax as a primary vaccine.
Vaxxinity of Dallas has kicked off a rolling submission to the U.K.’s Medicines and Healthcare products Regulatory Agency of its COVID-19 vaccine candidate as a booster. The shot is being tested as a booster for people who received a primary mRNA, adenovirus vector or inactivated virus vaccine.
UPDATED: Thursday, Sept. 8 at 11:15 a.m. ET
Pfizer donated 100,000 courses of its oral antiviral, Paxlovid, to the Covid Treatment Quick Start Consortium—a new group angling to improve access to the drug in low- and middle-income countries, Reuters reports. Set up by the likes of Duke University and the Clinton Health Access Initiative, the Consortium says it's working with health ministries in 10 countries to set up national test-and-treat programs.
Meanwhile, Pfizer has apparently been less generous in other areas, as researchers looking at next-gen COVID vaccines face hurdles accessing Pfizer’s Comirnaty and Moderna’s Spikevax, STAT News reports. Pfizer isn’t sharing its shot for research purposes, a spokesperson told STAT, while Moderna didn’t provide comment.
Speaking of coronavirus vaccines, new research out of Israel suggests the shots dramatically reduce the occurrence of long COVID, The Times of Israel reports. According to a peer-reviewed study, people who’ve received two doses of Pfizer and BioNTech’s vaccine saw at least a 50% reduction in 10 of the most common long COVID symptoms. Shortness of breath was slashed by 80%, for example.
Meanwhile, scientists from some of the top U.S. academic centers are uniting to suss out whether fragments of the coronavirus linger in the tissues of some people—which could shed light on the root cause behind long COVID, Reuters reports. Dubbed the Long Covid Research Initiative, the group is angling to streamline research and hustle potential treatments into the clinic. The effort includes scientists from Harvard University, Stanford University, the University of California, San Francisco and more.
The FDA is summoning a meeting of its Pulmonary-Allergy Drugs Advisory Committee to weigh Veru’s bid for emergency use authorization of sabizabulin for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The AdComm will meet on Oct. 6, the company announced early this week.
UPDATED: Tuesday, Sept. 6 at 11:15 a.m. ET
India authorized Bharat Biotech’s COVID-19 recombinant nasal vaccine for primary immunization of adults. A trial also is underway to determine the vaccine’s effectiveness as a booster for those who have already received the country’s two most common COVID-19 shots—AstraZeneca’s Covishield and Bharat’s Covaxin.
As China faces more COVID outbreaks and lockdowns, it has authorized CanSino’s inhaled vaccine for emergency use in the country as a booster. Last week, China also sanctioned Livzon’s COVID-19 shot as a booster. CanSino said that it now hopes for a government contract with China.
Chile has sanctioned a phase 2 clinical trial of Sinovac’s omicron-specific COVID-19 vaccine and its trivalent COVID-19 vaccine—which combines protection against ancestral, delta and omicron. The study will evaluate the effectiveness of the vaccines in those who have already received two booster doses of either Sinovac’s CoronaVac, mRNA or adenovirus-type vaccines.
Eiger BioPharmaceuticals of California says that its peginterferon lambda treatment for with mild-to-moderate COVID-19 is stalled in the submission process. The company says that it will provide additional information to the FDA that it believes could be supportive of an emergency use authorization. Story.
UPDATED: Friday, Sept. 2 at 10:50 a.m.
The CDC has signed off on the Moderna and Pfizer-BioNTech omicron-adjusted bivalent COVID-19 vaccines for booster use. The authorization for Moderna’s shot covers people 18 and older. For the Pfizer vaccine, the nod is for those 12 and older. The CDC is expected to expand booster use to the pediatric population, pending ACIP evaluation today.
Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended the Novavax COVID-19 vaccine for use as a booster in those 18 and older. The authorization would give adults in Europe the option to use a protein-based shot, regardless of the type of their previous vaccine. Also this week, the CHMP recommended the omicron-adjusted mRNA boosters from Pfizer-BioNTech and Moderna.
Pfizer and BioNTech have filed a motion against CureVac in the UK, saying their mRNA COVID-19 vaccine does not infringe on its patents and asking for dismissal of the case. The filing came in response to a lawsuit CureVac filed in July, asking for fair compensation for mRNA technology it developed. Moderna also has a claim of infringement against Pfizer and BioNTech, which was filed last week.
The FDA revised its authorizations for Lilly and Regeneron’s antibodies early in the year on data that suggested they weren’t effective against the omicron variant. Despite the FDA ban, hospitals and health systems administered more than 158,000 deauthorized monoclonal antibody doses in early 2022, a new JAMA study contends. Story
UPDATED: Thursday, Sept. 1 at 11:15 a.m.
One day after the FDA authorized the omicron-tweaked COVID-19 booster shots of Pfizer-BioNTech and Moderna, Europe’s Committee for Medicinal Products for Human Use (CHMP) has followed suit, recommending a nod from the European Medicines Agency. The one difference is that Moderna’s recommendation covers those 12 and older. The U.S. authorization for Moderna’s booster is for those 18 and older.
Vaxart has reported (PDF) positive data from the first of a two-part phase 2 study of its oral COVID-19 vaccine candidate, VXA-CoV2-1.1-S, which is designed to defend against omicron. Antibody levels rose after use of the pill, particularly in those who have already received an mRNA vaccine. Vaxart is the first company to advance a COVID-19 vaccine in pill form to phase 2.
Daiichi Sankyo has kicked (PDF) off a phase 3 trial of its mRNA COVID-19 vaccine DS-5670 in healthy, unvaccinated people. The trial of 322 people aims to show non-inferiority to Pfizer’s Comirnaty in terms of immunogenicity and seroconversion rate, the company said.
Another former Bristol Myers Squibb employee has sued the firm and human resources director Caitlin Freeland, alleging discrimination over her termination for refusing to be vaccinated against COVID-19. Oksana Chornomaz alleges that BMS acted unlawfully because vaccination was counter to her religious beliefs. In December of last year, four BMS employees filed a similar action, which remains unresolved.
