After more than three years, WHO said COVID-19 no longer represents a global health emergency. Plus, CDC director Rochelle Walensky is stepping down.

Please read below for the latest updates. COVID-19 tracker entries from Sep. 1 to Dec. 31 can be found here.

UPDATED: Friday, May 5 at at 1:10 p.m.

COVID-19 no longer represents a global health emergency, World Health Organization Director-General Tedros Adhanom Ghebreyesus said at a press conference Friday. WHO's International Health Regulations Emergency Committee made the call at its meeting this week, and the director-general said he agrees, CNN reports. Over the last year, the pandemic's downward trend has "allowed most countries to return to life as we knew it before Covid-19,” he added.

Meanwhile in the U.S., CDC director Rochelle Walensky is stepping down, President Joe Biden confirmed Friday. The White House didn't give a reason for her departure, NBC News reports. She had been CDC director since the start of the Biden administration in 2021.

UPDATED: Wednesday, May 3 at at 9:19 a.m. ET

Starting May 11, the United States will no longer require foreign travelers to be vaccinated against COVID-19, Reuters reports. The requirement ends along with the United States' national health emergency. 

Flagging possible "misrepresentations" around COVID-19 vaccines, Texas attorney general Ken Paxton is launching a probe into Pfizer, Moderna and Johnson & Johnson. The attorney general wants to know whether the companies misrepresented vaccine efficacy in possible violations of the Texas Deceptive Trade Practices Act. Release

The FDA is convening an advisory committee meeting to discuss the selection of the coronavirus strains to be included in COVID vaccines for the 2023-2024 season. The Vaccines and Related Biological Products Advisory Committee will meet on June 15. Government filing (PDF)

Amid a vaccine glut in Europe, Poland is asking Pfizer to be a good corporate citizen and show flexibility in renegotiating a supply deal. Pfizer said it couldn't comment on the letter from Poland's health minister to its shareholders. Story

UPDATED: Monday, May 1 at 9:55 a.m. ET

After a lucrative year in 2021, Sinovac said its revenues fell way down to $1.5 billion in 2022. That came after the company's COVID-19 vaccine efforts yielded an impressive haul of $19.4 billion in 2021. Outside of its COVID-19 vaccine, the company has several other marketed shots, including vaccines against flu and hepatitis A.

Under a new deal proposal, Europe would pay Pfizer and BioNTech half price for each canceled dose that authorities no longer want to purchase, the Financial Times reports. The parties are renegotiating their deal amid a decline in vaccine demand after Europe inked a massive deal to purchase doses. Not all European countries are on board with signing an amended deal, according to the newspaper.

A new COVID-19 variant called Arcturus could be associated with pink eye, according to health officials in Los Angeles. But during an active allergy season, it's too soon to say whether that is definitively the case.

UPDATED: Tuesday, April 18 at 10:15 a.m. ET

People in the U.S. who are looking to receive their first mRNA COVID-19 vaccine are set to get a single dose of the updated, omicron-targeting shots, The Wall Street Journal reports. For those 65 and older or those with weakened immune systems, the FDA also authorized a second booster with the updated vaccines.

Gilead Sciences shared real-world study findings showing that its antiviral Veklury was associated with a better chance of survival for COVID-19 patients who have cancer. In addition, the company touted phase 1 findings for its experimental antibody obeldesivir.

AstraZeneca believes its new antibody, AZD3152, could protect immunocompromised patients against all known variants, the company's vaccine and immune therapies chief Iskra Reic told Reuters. The company hopes to make the antibody available later this year.

UPDATED: Thursday, April 13 at 11:07 a.m. ET

After cutting some $50 million in costs in 2023’s first quarter, Novavax is just getting started, Reuters reports, quoting the beleaguered vaccine company’s chief executive John Jacobs. “We’re looking at everything from buildings, leases, land, headcount and contractors, every aspect of our company and the way we work,” Jacobs said in an interview with the news outlet. The news comes as Novavax works with the U.S. FDA on the potential design of its 2023 COVID booster, which Jacobs said the company could roll out by fall.

Overseas in India, the world’s biggest vaccine maker Serum Institute of India could restart production of AstraZeneca’s vaccine, rolled out locally under the Covishield moniker, a company spokesperson said. Those extra AZ doses would build on a supply of 6 million doses of Covovax, which is a version of Novavax’s vaccine, Reuters reports.

Amid a COVID-19 vaccine patent fight between Arbutus Biopharma, Pfizer and Moderna, the latter company has chalked up a win in a separate case. Moderna has “persuasively shown” that Arbutus tread on its intellectual property with a lipid nanoparticle (LNP) technology patent dubbed ‘127. After an appeal attempt by Arbutus, the U.S. Court of Appeals for the Federal Circuit has upheld Moderna’s victory. The patent in question isn’t part of Arbutus’ COVID suits against Pfizer and Moderna, meaning those disputes remain in play. Story

UPDATED: Tuesday, April 11 at 11:15 a.m. ET

President Joe Biden’s $5 billion follow-up to “Operation Warp Speed” is called “Project Next Gen” and will focus on next-generation vaccines and treatments. The effort will include speeding up development of vaccines that produce mucosal immunity as well as ones that guard against multiple COVID variants. Some of the lab work is already underway, The Washington Post reports.

President Biden also inked legislation to officially end the COVID-19 national emergency. That designation is separate from the public health emergency, which will end on May 11. The bill to wrap up the national emergency passed through the Senate last month, CNN reports.

A new COVID-19 variant is emerging in India with a new symptom. Combined with the known symptoms of fever and cough, variant XBB.1.16 causes “itchy” conjunctivitis, or pink eye but with “sticky eyes” and no pus, according to reports. The cases in children under 12 are steadily increasing in the country, Yahoo Finance reports. The strain has an increased ability to outdo other variants, meaning it could spread worldwide in the near future. 

Meanwhile in Australia, infections rates have increased over the last two months. Australian Medical Association president Steve Robson told The Guardian that more infections are likely, especially after Easter weekend. 

UPDATED: Wednesday, April 5 at 11:27 a.m. ET

Gilead Sciences tested its experimental COVID-19 antiviral in healthy volunteers and has started enrolling patients in two larger phase 3 trials. The drug works the same way as the company's other COVID treatment Veklury by inhibiting the viral RNA polymerase and targeting virus replication. The company believes that the drug could resolve symptoms earlier in a five-day course, Reuters reports.

InflaRx’s vilobelimab, branded as Gohibic, scored an FDA emergency use authorization to treat critically ill COVID-19 patients. It’s the first drug authorized to specifically block immune complement factor C5a, which is thought to contribute to inflammation and COVID worsening. It's only cleared for use within 48 hours of a patient receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Story.  

Pfizer and Merck both slightly lowered prices of their COVID-19 treatments in China, Reuters reports. Pfizer trimmed Paxlovid’s price by about 100 yuan ($14.54), while Merck brought Lagevrio's price down by 74 yuan ($10.76), according to the news service.

A new COVID-19 antiviral could be on the way from Shinogi. The Japanese company’s investigational oral med was granted fast track designation from the FDA after receiving emergency regulatory approval in Japan last November. It works by selectively inhibiting the viral 3CL protease over five days, Pharmaceutical Technology reports.

AstraZeneca’s COVID-19 vaccine, Vaxzevria, has been discontinued in Australia after other vaccines surpassed it in popularity. The vaccine hasn’t been available in the country since March 20 and the last batch in stock expired on March 21, The West Australian reports.  

UPDATED: Monday, April 3 at 10:45 a.m. ET

White House COVID-19 response team leader Ashish Jha is calling on doctors to fill an information void on the virus that has allowed widespread misinformation to spread. Speaking to the Massachusetts Medical Society, Jha urged physicians to fill the information vacuum “because if we don’t others will.”

An experimental treatment to restore the senses of taste and smell to those who lost it when struck with COVID-19 has shown promise. The Cleveland Clinic came up with the therapy—a numbing procedure called stellate ganglion block, which has been used to treat pain and post-traumatic stress disorder. The treatment, which is injected into the neck, is being used in hopes of kicking off a clinical trial.

Three years after the rise of the coronavirus pandemic, the World Health Organization is warning the next pandemic isn’t in the too distant future. And when it comes, the U.S. healthcare system could be ill-prepared according to a report from ABC News. Thirteen state health departments and 11 hospital associations have cited healthcare worker shortages and budget cuts as reasons for concern.

Pardes Biosciences' antiviral treatment has flunked a phase 2 trial. The company's board has already initiated a review of strategic alternatives that could include an acquisition, merger, business combination or other transaction. Story

UPDATED: Thursday, March 30 at 11:10 a.m. ET

The Senate voted 68 to 23 on a bill that proposes to end the national COVID-19 emergency. Now, it's up to President Joe Biden to decide on the bill. A White House official told CNN that while Biden “strongly opposes” the bill, his administration is already planning on winding down the emergency by May 11. However, the official said that if the Senate passed the measure, the president “will sign it.”

Meanwhile, the FDA is considering authorizing a second bivalent booster for people who are high risk because of their age or compromised immune systems, a federal official told NPR. So far, the FDA has only authorized one dose of the new boosters.

Women under 30 who received at least one dose of AstraZeneca’s COVID-19 vaccine may have been at an increased risk of dying of a heart problem in the 12 weeks following their vaccination, a new analysis of immunization and death records in Britain found. The analysis found six cardiac-related deaths per 100,000 young women who received the vaccine, The New York Times reports. However, the analysis did not prove that the vaccine caused the deaths.

The World Health Organization (WHO) is monitoring a new omicron subvariant called XBB.1.16. The strain has been recorded in 22 countries and the majority of cases are coming from India. In India, it has replaced the other variants in circulation, WHO’s COVID-19 technical lead Maria Van Kerkhove said at a press conference. The strain is one of more than 600 omicron subvariants that WHO is tracking, U.S. News & World Report reports.  

UPDATED: Tuesday, March 28 at 11:15 a.m. ET

At a hearing before the European Parliament’s Special Committee on COVID-19, European Union health commissioner Stella Kyriakides insisted that vaccine contracts with Pfizer were negotiated through proper channels and that EU Commissioner Ursula von der Leyen was not involved in the talks. Von der Leyen drew scrutiny nearly two years ago when she admitted to the New York Times that she traded texts with Pfizer CEO Albert Bourla discussing the contracts. Last month, the Times sued the EU for not making those texts public.

The World Health Organization has adjusted its COVID vaccination recommendations, moving healthy children into a "low priority" category, Reuters reports. For older adults and people with high-risk factors, the WHO recommends an additional shot either six or 12 months after the last dose.

This is shaping up to be a year of change for BioNTech as it revealed in its quarterly earnings that it expects COVID-19 vaccine revenue of 5 billion euros. The guidance fell significantly below consensus estimates. The lackluster prophecy reflects plummeting demand for booster vaccinations. But the German company is still ramping up R&D spend to around 2.4 to 2.6 billion euros in 2023, up from 1.5 billion euros last year. Story

Facing a flurry of lawmakers’ questions, Moderna CEO Stéphane Bancel refused to buckle under pressure before the Senate Health Committee Wednesday. The helmsman defended his company’s planned price hike on its mRNA-based COVID shot. Story

The brief commercial run of Brii Biosciences' long-acting COVID-19 antibody combination of amubarvimab and romlusevimab is over. Brii will stop manufacturing the cocktail in China and has pulled its submission for emergency use authorization in the United States, the company said. Story

UPDATED: Wednesday, March 22 at 9:52 a.m. ET

After stalling vaccines from BioNTech and Moderna, China has authorized its first mRNA shot, an omicron-targeted version domestically made by CSPC Pharmaceutical, Bloomberg reports. In a local study of 4,000 participants from Dec. 10 to Jan. 18, when infections were surging, the vaccine showed an efficacy rate of 85.3% up to four weeks after a booster vaccination, the company said. 

The FDA could make a decision on a new round of booster shots in the coming weeks, The Wall Street Journal reports, citing people familiar with the agency's discussions. The shots would be for people who are 65 years and older or who have weakened immune systems. 

Moderna CEO Stéphane Bancel will defend Moderna's $130-per-shot COVID vaccine price before the Senate's HELP Committee today. In a recent speech, Sen. Bernie Sanders, chair of the committee, called Moderna a “poster child” for pharma greed.

Yale School of Medicine is launching a new study to examine the effect of Pfizer's Paxlovid on long COVID. The randomized trial adopts a decentralized design as participants don't have to travel to study sites. Instead, the study will collect data with digital devices. The study will enroll 100 previously healthy people who are suffering from long COVID. 

UPDATED: Monday, March 20 at 9:30 a.m. ET

World Health Organization director general Dr. Tedros Adhanom Ghebreyesus called on China to release data that could provide answers about the origin of the pandemic. As The New York Times reports, the data had been briefly posted online but were later removed. A team of scientists said the information suggested that raccoon dog trading at the now-closed Huanan Seafood Market could be the key to the source of the novel coronavirus, according to reports.

After a recent meeting with the FDA, Toronto-based Revive Therapeutics says it's keeping the primary endpoint unchanged for a phase 3 study testing its oral drug bucillamine. Revive plans to continue discussions with the regulator "on a pathway for future potential regulatory approval under the current study’s objectives," Revive said in a press release. At the same time, the company is working on reformulation strategies and is looking for a pharmaceutical partner to achieve the drug's "full commercial potential."

UPDATED: Wednesday, March 15 at 9:45 a.m. ET

Pfizer's bivalent omicron booster is now authorized for use in kids between 6 months and 5 years of age in the U.S. The FDA signed off on the vaccine for children who have received the three-dose primary series. The authorization gives parents and caregivers "an opportunity to update their children’s protection" with the bivalent booster, FDA Center for Biologics Evaluation and Research director Peter Marks, M.D., Ph.D., said in a statement.

After many months of scrutiny around Europe's vaccine supply deal with Pfizer, the company agreed to reduce dose deliveries and extend the timeline of the deal, The Financial Times reports. But Pfizer still expects payments for doses that won't be delivered under the new deal, according to the newspaper. Story

Ahead of a Thursday advisory committee meeting, FDA staffers said that the data on Pfizer's Paxlovid support a full approval in high-risk COVID-19 patients who are suffering from mild to moderate symptoms. While Paxlovid has been available under an emergency use authorization, a full approval could allow Pfizer to expand its marketing of the oral drug, Reuters reports.

UPDATED: Wednesday, March 8 at 1:00 p.m. ET

The House Select Subcommittee on the Coronavirus Pandemic met for its first COVID origin hearing today. Witnesses included Dr. Robert Redfield, who Trump appointed as CDC director, and Dr. Paul Auwaerter, a professor of medicine at the John Hopkins University School of Medicine. Experts have said that regardless of the hearings, a full investigation of the virus’ origins will require more cooperation from the Chinese government, ABC News reports. Dr. Redfield said at the hearing that he concluded that the virus was the result of an accident, The New York Times reported.

The Biden administration plans to end the policy requiring negative COVID-19 tests from passengers traveling from China, according to three officials who anonymously described the plan to The Washington Post. The policy could be lifted as soon as Friday.

Akston Biosciences has cut ties with Stelis Biopharma, taking back all rights to its room temperature stable, low-cost protein subunit COVID-19 vaccine candidate, AKS-452. The vaccine has been through clinical trials and Akston is now working with a contract manufacturer in India to produce the vaccine. Todd Zion, the company’s president and CEO, said he is “confident” that the vaccine can secure emergency use authorization in India, Contract Pharma reports.

UPDATED: Tuesday, March 7 at 8:32 a.m. ET

Speaking at the Wall Street Journal Health Forum, Moderna CEO Stéphane Bancel said investor capital—not government money—funded the company's early pandemic response. He defended the company's plan to raise prices when the U.S. shifts to a private market, but he stressed that Moderna has plans to ensure access for individuals.

The United Kingdom's Joint Committee on Vaccination and Immunisation has revealed a spring booster plan, The Guardian reports. New booster doses are set to be available to immunocompromised people 5 and older, plus adults 75 and older and those living in care homes.

UPDATED: Friday, March 3 at 10:50 a.m. ET

In a commentary in The Wall Street Journal, the World Health Organization said it has "neither 'abandoned' nor quietly shelved the search for" SARS-CoV-2's origins, refuting recent media reports that it has ditched the second phase of its investigation. 

The FDA has denied Veru's sabizabulin an emergency use authorization in hospitalized patients with moderate to severe COVID who are at high risk for acute respiratory distress syndrome. Despite the rejection, the FDA provided guidance on the design of a proposed phase 3 trial of the drug. Veru said it expects to communicate more details on the phase 3 study soon. In a previous phase 3, sabizabulin led to a 24.9% absolute reduction in deaths compared with placebo in hospitalized patients. But the result came from just 150 patients. 

Pfizer has partnered with diagnostic firm Cue Health to raise awareness of the risks of progressing to severe COVID-19. “Our collaboration provides an opportunity to improve the test-to-treatment experience for patients and communities at high risk, which includes people 50 years of age and older,” JoyL Silva, the global and U.S. antiviral franchise lead at Pfizer, said in a statement. Story

UPDATED: Wednesday, March 1 at 9:55 a.m. ET

Novavax generated nearly $2 billion in revenues last year, but the company still isn't sure if it will be able to operate beyond 2023. The company is running out of government funding later this year, and a high-stakes arbitration case with global vaccine alliance Gavi could prove costly. Story

Shortly after the U.S. Energy Department concluded with "low confidence" that a lab leak in China likely caused the pandemic, FBI director Christopher Wray said his agency has reached the same conclusion. Wray added that it seemed the Chinese government was trying to "thwart and obfuscate" efforts to find the source of the pandemic.

The European Commission's ombudsman, Emily O'Reilly, told Reuters that EC president Ursula von der Leyen's refusal to reveal texts she exchanged with Pfizer CEO Albert Bourla is a problem that "won't go away." Previously, EC concluded that the texts weren't required to be released, a spokesperson told the news service. The texts have been at the center of an investigation into how Europe inked its largest vaccine contract with Pfizer.

UPDATED: Monday, Feb. 27 at 8:30 a.m. ET

After reviewing new intelligence, the U.S. Energy Department has concluded that the pandemic was likely caused by a lab leak, The New York Times reports. But officials told the newspaper that the finding was reached with "low confidence." Other government agencies did not change their own conclusions about the pandemic after reviewing the undisclosed new intelligence, NYT notes.

Shionogi believes its COVID-19 antiviral pill could pull in at least $2 billion in annual sales if it's able to secure a U.S. approval, Reuters reports. The company hopes to get an FDA nod late next year. The drug, Xocova, has won an approval in Japan and is competing against antivirals from Pfizer and Merck in Shionogi's home country.

UPDATED: Thursday, Feb. 23 at 8:50 a.m. ET

Pfizer is in a position to continue growing Comirnaty sales despite recent worries about declining demand, analytics firm GlobalData says. The firm projects Comirnaty sales will grow 16% this year thanks to new booster approvals in "key geographies." Beyond 2023, the analysts say the U.S. commercial market will fuel growth in 2024 and beyond.

In a survey conducted by LogiPharma, a conference for supply chains in the life science industry, eight of 10 biopharma companies said COVID-19 research projects have affected their larger pipeline efforts. The pandemic was a "resilience test for the continuity of clinical trials for our entire portfolio," Merck global head of customer integration David Ruiz said in a statement. 

CDMO GenScript ProBio has agreed to produce plasmid DNA for RVAC Medicines as the latter company pursues development of an mRNA COVID-19 vaccine candidate. The manufacturing deal includes potential collaborations on future pipeline projects.

UPDATED: Tuesday, Feb. 21 at 2:00 p.m. ET

High-risk patients in the U.K. will have access to Pfizer's Paxlovid, GSK's Xevudy and Roche's RoActemra under new guidance published by England's National Institute for Health and Care Excellence. The drugs are recommended for different groups of patients depending on their exact situation, but NICE found each option cost-effective in the right circumstances.

Merck's Lagevrio has been a big moneymaker for the New Jersey drug giant, but it has struggled at times in clinical testing. Now, in a phase 3 study, the drug failed to meet the statistical significance bar in cutting the risk of contracting COVID-19 for people who had been exposed to the virus through a household contact. Story

In a phase 3 trial, Shionogi's Xocova met its primary and key secondary endpoints in patients with mild or moderate COVID-19 in Japan, South Korea and Vietnam. Compared with placebo, the drug reduced the time to resolution of five COVID-19 symptoms. It also cut the time to achieve a negative infectious viral titer, Shionogi said. The drug is approved in Japan but remains investigational elsewhere.

Gilead Sciences' Veklury has been found to cut the risk of death in hospitalized patients with COVID-19 "across all variant time periods" in a large real-world study. The drug was associated with a statistically significant reduction in mortality risk in an overall patient population, including those who are immunocompromised, Gilead said. For this study, the team looked at data from more than 500,000 hospitalized adults.

UPDATED: Wednesday, Feb. 15 at 3:05 p.m. ET

It's the feds, not Moderna, that ought to be on the hook for any infringement of Arbutus Biopharma and Genevant Sciences’ patents that took place under government contract to produce COVID-19 shots, the Department of Justice said in a Delaware court filing. Moderna made the same claim last year when it failed to secure an early dismissal of the lawsuit, Reuters points out. Arbutus and Genevant sued Moderna in 2022, seeking royalties on the biotech’s megablockbuster COVID shot Spikevax.

Speaking of COVID shots, the European Medicines Agency plans to make the inoculations an annual affair, similar to the flu vaccine, the regulator said Wednesday. COVID-19 isn’t yet behaving like a seasonal virus such as influenza, though “this might be the direction it will be going,” said Marco Cavaleri, EMA’s head of health threats and vaccine strategies, as quoted by Reuters.

With COVID-19 cases on the decline and vaccines readily available, the World Health Organization is powering down the Independent Allocation of Vaccines Group (IAVG), The Economic Times reports. IAVG was previously established to validate and assess vaccine allocations through the Covax facility. IAVG could be resurrected if the need arises in the future. 

UPDATED: Tuesday, Feb. 14 at 9:51 a.m. ET

In its Vir Biotechnology partnership, GSK is cutting future research on COVID-19 vaccines and antibodies. The company is sticking with its partner on flu and other respiratory disease research, and it's still supporting the rollout of Xevudy where it's already available. Story

The FDA announced the recall of more than 56,000 rapid antigen tests from Universal Meditech. The company distributed the products "without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA," the agency said.

As part of its effort to dig into the European Commission's vaccine deal with Pfizer, The New York Times is suing officials for keeping their text messages secret, reports. The European Commission was expected to comment on the case Tuesday, according to the report.

After 12 years of leadership under Dr. Seth Barkley, Gavi, The Vaccine Alliance, announced that Dr. Muhammad Ali Pate will become the organization's next CEO. Gavi has been instrumental in getting COVID-19 vaccines to people in low- and middle-income countries around the world.

UPDATED: Monday, Feb. 13 at 10:41 a.m. ET

Novavax and the U.S. government agreed to a COVID-19 vaccine contract modification. Under the amended deal, the U.S. will buy up to 1.5 million more doses of the company's shot. In addition, the deal supports development of an updated vaccine, the Maryland-based biotech said.

In Japan, officials canceled an order of nearly 142 million Novavax COVID-19 vaccines, Takeda revealed in a SEC filing (PDF). It's the latest setback for vaccine manufacturers amid a global slowdown in demand for the shots. Takeda and Novavax partnered on the vaccine for the Japanese market back in 2020.

Meanwhile, after The New York Times reported that Johnson & Johnson sought payment for undelivered vaccines, some investors are pushing back. In a letter to CEO Joaquin Duato, the faith-based investor group ICCR said the allegation "verges on extortion."

On the therapeutic front, Pfizer recently launched a branded ad for its antiviral Paxlovid. The drug is still marketed under an emergency use authorization and a full FDA approval is pending. Story

UPDATED: Friday, Feb. 10 at 10:40 a.m. ET

Health officials in New York State will allow mask mandates in hospitals and other healthcare facilities to end on Sunday, multiple news outlets have reported. The pivot follows a steady decline in local transmission rates over the past two months, NY health department data show. That isn’t to say masking will be eradicated altogether, as individual policies will still be left up to each healthcare facility. In New York City, Mayor Eric Adams recently said the city would lift its vaccine mandate for workers because 96% of the city’s workforce had received their primary COVID-19 vaccination series.

The U.S. House of Representatives has voted to end a requirement that most foreign air travelers be vaccinated against COVID, Reuters reports. The policy rollback comes after the Biden Administration in June dropped the stipulation that people arriving in the U.S. by plane need to test negative for COVID, though CDC vaccination requirements for most foreign travelers remain in place. The White House said it was opposed to the bill on Tuesday, and it remains unclear if the Senate will take it up, Reuters notes.  

In another sign of the times, the Centers for Disease Control and Prevention has added COVID-19 shots to its schedules of routinely recommended vaccines for kids and adults. According to CDC data, nearly 80% of adults in the U.S. have completed their primary COVID-19 vaccination series. By comparison, just 19.2% of people ages 18 and up have received an updated bivalent booster dose.

And while the Biden Administration is set to declare an official end to the COVID-19 public health emergency this May, that doesn’t necessarily portend immediate changes in the U.S. landscape of coronavirus tests, treatments and vaccines, Fierce Medtech reports. In short, even though the public health emergency is set to end, the authority granted by emergency use authorizations (EUA) generally continues until it is terminated by the Department of Health and Human Services secretary, and with public notice in advance. Story

UPDATED: Wednesday, Feb. 8 at 9:00 a.m. ET

Starting Friday, New York City municipal employees will no longer be required to be vaccinated against COVID-19, NPR reports. The change comes about 18 months after the city implemented the vaccine requirement. In a statement, mayor Eric Adams said more than 96% of city employees are already vaccinated.

In California, education officials are abandoning a plan to require COVID-19 vaccines for schoolchildren, San Francisco-based KQED reports. The state's emergency declaration ends later this month.

Tuesday night during his State of the Union speech, President Joe Biden said the U.S. has "broken COVID’s grip on us." COVID-19 deaths are down more than 90%, the president said, and the government will soon end its emergency declaration. But he remembered the more than 1 million U.S. lives lost to the pandemic.

While many big pharma companies saw stock price gains in 2022, the opposite was true for pandemic stars Pfizer, Moderna and Roche. After major gains in 2021, their share prices corrected in 2022. Moderna's share price fell 33% in 2022, while Roche's dropped 32% and Pfizer's slipped 13%. Story

UPDATED: Monday, Feb. 6 at 1:35 p.m. ET

FDA Commissioner Robert Califf and CDC director Rochelle Walensky are among the administration officials who are set to testify Wednesday before Congress on the government response to COVID-19. Vaccine safety is expected to be primary topic. Republican leaders who pushed for the hearings said in statement that government health agencies have “lost the American public’s trust due to misguided mandates and lockdowns.”

Companies that manufacture products to combat the coronavirus pandemic are facing a “steep COVID cliff” in 2023 with sales declining markedly, according to a report in Reuters. Analysts point to investor pressure on companies such as Pfizer, Moderna, Merck and Eli Lilly to turn their COVID profits into M&A and R&D gains.

UPDATED: Thursday, Feb. 2 at 10:17 a.m. ET

A preprint study from researchers on both sides of the Atlantic has linked Merck's antiviral pill Lagevrio with new coronavirus mutations, Bloomberg reports. So far, the novel mutations the team tracked are not more lethal or infectious than existing variants. A Merck spokesperson is quoted in the Bloomberg article as saying there is "no evidence to indicate that any antiviral agent has contributed to the emergence of circulating variants."

As the COVID-19 response continually shifts in the U.S., regulators are making it easier to get antiviral pills from Pfizer and Merck. The FDA has removed the requirement that patients test positive for COVID-19 in order to qualify for the drugs, Reuters reports.

With demand for vaccines slipping, officials at the global vaccine group Gavi have sought to renegotiate supply deals, The New York Times reports. But companies such as Moderna and Novavax are refusing to cancel supply deals or give refunds for pre-paid doses, according to the newspaper.

UPDATED: Tuesday, Jan. 31 at 8:51 a.m. ET

The Biden administration plans to end the COVID-19 public health emergency on May 11. The plan came in response to two bills in the House of Representatives that sought to end the emergency declaration sooner, Fierce Healthcare reports. The Trump administration enacted the public health emergency in early 2020 and it has been extended several times since. With the change, patients, hospital officials and others will need to brace for changes to the ways treatments and tests are paid for, Kaiser Health News reports.

Pfizer has been riding a wave of sales from pandemic countermeasures, but that momentum looks set to end in 2023. The company projects a 64% decline for COVID-19 vaccine Comirnaty this year and a 58% decline for antiviral Paxlovid. As for last year, Comirnaty pulled down $37.8 billion and Paxlovid generated $18.9 billion.

UPDATED: Monday, Jan. 30 at 9:57 a.m. ET

China’s relaxation of its strict zero-COVID policy could portend a sales boost for Pfizer’s antiviral Paxlovid there, Reuters reports. Originally a small market for Paxlovid, Pfizer chief Albert Bourla has said that since the policy was lifted, Pfizer has distributed millions of courses of the company’s treatment in China through a deal with Meheco. That said, the status of deliveries later in 2023 remains murky, Reuters points out. The news outlet reports that talks between Pfizer and China's government health insurer have stymied over price, while Paxlovid is only covered by China's broad healthcare insurance plan until late March.

Plus, China is building out its own home-grown armamentarium of COVID medicines, Reuters points out. The country on Sunday approved two domestically developed therapeutics for adult patients suffering from mild to moderate COVID-19. The drugs were developed by Simcere Pharmaceutical and a unit of Junshi Biosciences, Reuters notes.

Meanwhile, Pfizer is attempting to “set the record straight” after allegations of gain of function and directed evolution research at the company. First, Pfizer stresses it “has not conducted gain of function or directed evolution research,” the company said in a statement issued Friday. Further, to track Paxlovid’s activity against coronavirus mutations, Pfizer on occasion engineers virus to assess the activity of its antiviral, but notes that “these studies are required by U.S. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. and around the world.”

The pharma industry’s pandemic reputation glow-up seems to have dimmed, according to a new report out by Caliber, which found that in 2022 only four out of 10 people were likely to say something positive about a pharma company. Haleon, which recently spun out from GSK’s consumer unit, ranked as the most respected brand in the survey. On the other end of the spectrum, Novartis, Johnson & Johnson, Moderna, Pfizer and AstraZeneca are among the worst-perceived companies in the sector, with all but Novartis vaccine makers for COVID. Story

UPDATED: Friday, Jan. 27 at 10:55 a.m. ET

Europe is engaged in discussions with Pfizer and BioNTech surrounding the possibility of reducing the 500 million COVID-19 vaccine doses the bloc has committed to buying this year in exchange for paying a higher price, a source with knowledge of the talks told Reuters. Also being discussed is the possibility of extending the delivery deadline to the second half of 2024, according to the source.

An FDA advisory committee voted unanimously to recommend that all vaccines going forward should be bivalent. That would mean that the primary series and boosters would be interchangeable. The committee also considered an annual COVID vaccination schedule, similar to flu vaccines. Story

UPDATED: Thursday, Jan. 26 at 9:29 a.m. ET

A polymerase chain reaction test—which can detect the rapidly spreading XBB.1.5 omicron variant—has been launched by Roche, the company said. The test will help researchers track the progress and lineage of the variant.

Bharat Biotech’s nasal COVID-19 vaccine, BBV154, which was approved for emergency use in India in November, has been launched in the country. The vaccine has been sanctioned for booster use in adults. Bharat has priced the vaccine at 325 rupees ($4) for the government and 800 rupees ($9.81) for private markets.

A report from Australia—citing the experience of two subjects—suggests that taking a non-mRNA COVID-19 vaccine to avoid myocarditis after experiencing it with mRNA vaccines from Pfizer or Moderna is not a good strategy. In the two cases, recipients had additional heart problems after taking Novavax’s conventional COVID vaccine.

Sens. Elizabeth Warren (D-Mass.) and Peter Welch (D-Vt.) have sent a letter to Moderna CEO Stéphane Bancel questioning the company about its pricing strategy for its COVID-19 vaccine. The company has said it would price its adapted version of Spikevax at between $110 and $130 per dose when the United States goes to a commercial model this year. Warren and Welch are piggy-backing on a similar appeal to Moderna, earlier this month by Sen. Bernie Sanders (I-Vt.), which the White House also supported. Warren and Welch sent a similar letter last month to Pfizer, which also has said it would price its COVID vaccine at up to $130. Story

UPDATED: Tuesday, Jan. 24 at 1:50 p.m. ET

Over the past few months, anti-vaxxers have rallied behind the hashtag #DiedSuddenly, linking any deaths or even grave injuries—including the sudden collapse of the Buffalo Bills player Damar Hamlin—to COVID vaccination, The Atlantic reports. The movement is fueled by a conspiracy theory video bearing the same moniker. Twitter had originally flagged the documentary as misinformation but later removed the label in November when the social media platform stopped enforcing rules about COVID misinformation.

Axcella said it has gained clarity on a regulatory path for its long COVID drug candidate, AXA1125. The company has filed a phase 2b/3 trial application with the FDA, while suggesting it's also aligned with the U.K.'s Medicines and Healthcare products Regulatory Agency on a registrational trial. The drug previously posted mixed results in a phase 2a study, having failed on the primary endpoint but showed improvement on fatigue scores.

An analysis of compensation claims in the state of New York found long COVID could have a significant impact on a person's ability to work. About 71% of people classified by the New York State Insurance Fund as having long COVID either required further medical treatment or were unable to work for at least six months, The New York Times reports. Eighteen percent of long COVID patients had yet to return to work after one year, the report found.

The U.K. government wouldn't disclose financial details of its massive mRNA collaboration with Moderna, The deal, worth 1 billion pound, is aimed at building Britain's mRNA capabilities, including R&D and vaccine manufacturing. But how that money will be spent is less clear.

UPDATED: Monday, Jan. 23 at 11:21 a.m. ET

After years of speculation about the future of the COVID market, the FDA is making its preference clear. The agency will propose an annual dose of updated vaccines to a panel of external advisors, according to briefing documents submitted by the FDA. It asked the panel to consider two shots a year for young children, older adults and those with compromised immunity. The FDA expects that simplifying annual immunization schedules can contribute to simplified vaccine development, fewer administration errors and “less complex” communications, Reuters reports.

The threat of a “tripledemic” of flu, COVID and RSV hasn't fully panned out. Early waves of RSV and the flu peaked before New Year’s, new data from the CDC show. Plus, the seven-day national average of hospital patients testing positive for COVID has declined to 39,000 as of Friday, a surprise as the virus usually spreads faster in the winter. COVID patients are now occupying 5% of hospital beds, compared with 21% this time last year, the Washington Post reports.

Bharat Biotech will launch its intranasal COVID vaccine on January 26. The vaccine, the first of its kind to be made in India, is already approved by the country’s regulatory agency as a heterologous booster dose, meaning it can be used as a booster after any other COVID vaccine.

UPDATED: Friday, Jan. 20 at 10:20 a.m. ET

Moderna’s CEO Stephane Bancel is envisioning a world where the company’s mRNA vaccines can be made on every continent. "We're talking to a couple more countries because I would really like on every continent to have MRNA capacity," he said on a panel at the World Economic Forum annual meeting in Davos, Switzerland, as quoted by BW Business World. The company is building or plotting mRNA factories in Canada, Australia, Britain and Kenya, Bancel pointed out.

Speaking of mRNA COVID vaccines, Sinopharm just nabbed approval to run studies of its mRNA shot targeting Omicron in China, Reuters reports. Sinopharm recently became the China distributor for Merck & Co.’s antiviral molnupiravir, which launched in the country last week.

Elsewhere in China, Fosun Pharmaceutical and Genuine Biotech said they plan to team up with multiple companies to boost production of their oral COVID antiviral azvudine. Azvudine became China’s first homegrown oral antiviral after its approval there last summer. Since then, the companies have said demand for the therapeutic has surged following the dismantling of the government’s zero-COVID restrictions.

UPDATED: Thursday, Jan. 19 at 9:35 a.m. ET

After the CDC disclosed a probe into "very unlikely" stroke risks for Pfizer's updated COVID-19 booster, officials in Europe and Israel found no link, Reuters reports. Earlier this week, the CDC said one of its safety systems flagged a potential stroke risk in people 65 and older, but that subsequent investigations failed to confirm the signal. Story

Speaking at the World Economic Forum in Davos, Switzerland, Novartis CEO Vas Narasimhan said he expects the COVID-19 pandemic to shift into an "endemic environment" with "sporadic outbreaks." Right now, it's crucial to "turn our attention to pandemic preparedness for the future," Narasimhan added, as quoted by CNBC.

Early data from Johns Hopkins University shows that COVID-19 killed fewer people in the U.S. in 2022 than prior years, CNN reports. The illness claimed the lives of 267,000 people in the U.S. last year compared with 350,000 in 2020 and 475,000 in 2021, according to the preliminary data.

UPDATED: Tuesday, Jan. 17 at 11:00 a.m. ET

Manufacturers of COVID-19 vaccines pressured Twitter to silence activists who were pushing for release of intellectual property and patents which could lead to development of a generic shot, according to a report in The Intercept. The report included an email sent by a BioNTech spokesperson to Twitter requesting it to monitor and suppress related traffic.

Contracting COVID during pregnancy increases the risk of death by seven fold, according to a report in BMJ Global Health. Pooled data spanning 13,000 pregnant women in 12 countries, including the U.S. also showed that infants born to those who are infected were twice as likely to need treatment in the intensive care unit. 

The effects of long COVID have been “massively exaggerated” as a scare tactic, argues Johns Hopkins University School of Medicine professor Marty Makari in an opinion piece in CuencaHighLife, a news source for English-speaking expats in Ecuador. Makari presents evidence from studies that show the threat has been inflated in the U.S. to support the pharma industry.

Pfizer and BioNTech’s updated COVID-19 booster has been flagged by a safety monitoring system to a particular type of brain stroke in the elderly, the CDC says. A possible risk of brain ischemia—caused by blockages in arteries that carry blood to the brain—has not been identified by studies or other databases, said the companies and the CDC, which added that more investigation is needed.

UPDATED: Friday, Jan. 13 at 11:30 a.m. ET

Daiichi Sankyo of Japan has requested in its home country approval of its mRNA vaccine as a booster. A 5,000-person trial of the candidate, DS-5670, showed it produced an antibody response that was at least as strong as that from mRNA shots by Moderna and Pfizer-BioNTech.

Amid a wave of COVID infections, frustration is rising in China over the difficulty in accessing oral antivirals Paxlovid (Pfizer) and Lagevrio (Merck). Both companies have balked at the country’s efforts to secure the treatments at a reduced price. Meanwhile—amid shortages and high prices of the drugs—unauthorized versions of the drugs are circulating. Also on Thursday, the World Health Organization claimed that China is underreporting COVID deaths.

AstraZeneca has signed a deal with Genertec Meheco to import and distribute COVID-19 therapy Evusheld in China. The deal is pending approval of the antibody treatment in the country. Evusheld has been shown to be effective against pre and post exposure to the virus. But it also has since been found to be ineffective against some variants.

Johnson & Johnson is winding down production of its disappointing COVID-19 vaccine, said the Wall Street Journal, which chronicles the dissolved partnerships it forged to produce the shot—including one with Merck which is in arbitration. Story

The Biden administration has joined the growing chorus against Moderna’s pricing of its COVID-19 booster as White House press secretary Karin Jean-Pierre said during a briefing that it was “hard to justify.” Moderna CEO Stephane Bancel told the Wall Street Journal on Monday that it would charge between $110 and $130 for its booster when the U.S. goes this year to a commercial model for COVID shots. That prompted Sen. Bernie Sanders (I-Vt.) to send a letter to the company calling the price hike “unacceptable corporate greed.” Pfizer has proposed the same price range for its COVID shot.

UPDATED: Wednesday, Jan. 11 at 11:20 a.m. ET

In a letter to Moderna, Sen. Bernie Sanders (I-Vt.) has accused the company of “unacceptable corporate greed,” in its plan to jack the price of its COVID-19 vaccine up four fold. Sanders implored the company to consider the government’s role in facilitating Moderna’s rapid development of the vaccine and its newfound status as a commercial powerhouse. Moderna has said it plans to charge up to $130 per shot when the U.S. goes to a commercial model for COVID vaccines.

Moderna also has drawn the ire of FDA advisors who say the company didn’t present preliminary data on its COVID-19 booster that suggest the reconfigured shot may not be any more effective than the company’s original version. “I was angry to find out that there was data that was relevant to our decision that we didn’t get to see," Dr. Paul Offit, a member of the FDA's Vaccines and Related Biological Products Advisory Committee, told CNN.

Merck and Pfizer are resisting efforts by China to secure their oral antiviral COVID treatments at reduced prices. A local news outlet reported that Merck is selling Lagevrio for $221 for a course of treatment, which is less than the company charges in many other western countries. Talks between Pfizer and China have also stalled. Meanwhile, the launch of Lagevrio in China is set for Friday, another local news outlet reported.

In a related story in China, Merck said it will take legal action against some pharma companies in the country that are providing unauthorized COVID treatments to some jurisdictions and claiming they’ve been authorized by Merck.  

UPDATED: Monday. Jan. 9 at 2:23 p.m. ET

Moderna, similar to rival Pfizer, is eying a higher commercial price in the U.S. for its mRNA vaccine, CEO Stéphane Bancel told The Wall Street Journal at the J.P. Morgan Healthcare Conference. The drugmaker is reportedly eying a price of $110 to $130 per dose, which would be several times higher than the price the government paid for public contracts. So far, vaccines have been provided for free under government supply deals.

Pfizer's antiviral Paxlovid recently launched in China but the drug has failed to pick up national reimbursement there, The Associated Press reports. Officials in China rejected the drug for a nationwide reimbursement program over cost concerns, according to AP.

UPDATED: Thursday, Jan. 5 at 4:04 p.m. ET

Over the month of December, the percentage of new COVID-19 infections in the U.S. caused by new Omicron subvariant XBB.1.5 rose from about 4% to 41%, leading healthcare experts to advise that the public stay informed but not alarmed, CNN reports. The subvariant has spread to at least 29 countries and is “the most transmissible form of Omicron to date,” said Maria Van Kerkhove, an epidemiologist who is the World Health Organization's technical lead on COVID-19.

Japanese drugmaker Shionogi & Co. submitted data to Chinese regulators for its COVID-19 pill, which it expects to be authorized for use as early as this quarter, Chief Executive Officer Isao Teshirogi told Bloomberg. If approved, China would have its third foreign antiviral to treat COVID. The drug has already been approved in Japan to treat patients 12 years and older and requires fewer pills than Pfizer's Paxlovid and Merck's Lagevrio.

The Transportation Security Administration (TSA) issued an extension of the United States' COVID-19 vaccine mandate for foreign travelers. President Joe Biden issued the original mandate in October of 2021 and it will now go through at least April 10, 2023, thanks to health officials warnings of a winter surge, Fox Business reports.

UPDATED: Wednesday, Jan. 4 at 1:31 p.m. ET  

The pandemic "darling" Pfizer is entering a "show me" phase, Bank of America analyst Geoff Meacham said in a note Wednesday. The analyst projects dwindling COVID-19 product sales from the pharma giant in 2023 and 2024, according to a report from Investor's Business Daily.

Speaking of Pfizer, the company's popular antiviral Paxlovid is available in China. More than a dozen community-level medical centers in Shanghai now have the treatment available, China Daily reports.

After China relaxed COVID-19 mitigation measures, the virus is wreaking havoc there. In Shanghai, up to 70% of the population is infected, according to a medical official.

UPDATED: Tuesday, Jan. 3 at 10:40 a.m. ET

Seven former AstraZeneca employees who were fired for refusing to be vaccinated against COVID-19 have filed a lawsuit in Delaware against the company claiming age discrimination. All of the plaintiffs are over age 40 and had filed for religious exemptions to the company’s vaccination policy. Citing a 2021 presentation by the company that said its average age of 48, the complaint alleged that AZ “devised a strategy to eliminate older employees.”

As China pulls away from its zero-COVID approach to taming the virus, it is adopting more remedies from the West. Last week, the country authorized the import of Merck’s COVID treatment Lagevrio (molnupiravir) for those who have been infected and are at risk to progress to a more severe form of the virus. Three weeks ago, China finalized a deal with state-owned China Meheco to import and distribute its COVID treatment Paxlovid.

Merck’s Lagevrio does not reduce the risk of hospitalization or death from COVID-19 among high-risk patients, according to a study conducted at the University of Oxford. The antiviral pill, however, provided faster recovery time and reduced viral detection and load, the study found.

Everest Medicines plans to file for authorization of its mRNA bivalent COVID-19 booster this year in China. The company also will launch trials of the shot in the country. The news came with the company’s reveal of its overall strategic plan for the next two years. In September of 2021, Everest and its mRNA partner Providence Therapeutics of Canada revealed a deal to manufacture and distribute vaccines in China.