Under a Biden administration plan, Pfizer's Paxlovid will soon be available at all U.S. pharmacies. 

The White House COVID-19 response coordinator says hospitalizations are at their lowest rate.

Meanwhile, regulators in Europe issued Valneva a list of questions about its vaccine candidate.

Please read below for the latest updates. Daily COVID-19 tracker entries from Jan. 4 to April 13 can be found here. 

UPDATED: Monday, April 25 at 10:13 a.m. ET

Americans will soon be able to pick up Pfizer’s Paxlovid at pharmacies across the country, Bloomberg reports. The Biden administration will outline a plan next week to allow every pharmacy to order the antiviral from the federal government, according to an unnamed official. Paxlovid is currently available at 90% of Rite Aid stores across 17 states, with supplies varying by location. The U.S. government has ordered 20 million courses but is waiting on lawmakers’ authorization to complete the purchase. “We’re working to make sure doctors and patients know about Paxlovid,” White House spokeswoman Karine Jean-Pierre said Thursday. While the pill fell into limited supply after its December FDA approval, “that’s not the case anymore,” Jean-Pierre said. “It’s widely available, and the eligibility criteria are pretty expansive.”

Omicron’s BA.2 variant has dominated COVID-19 cases across the country, with a 50% rise in virus cases across the past two weeks. Despite the rise, hospitalizations are at their lowest point, leading White House COVID-19 response coordinator Ashish Jha to remain “confident that we’re going to get through this” without disruption, he said on CNN’s Sunday show “State of the Union.” With 200 million Americans vaccinated, the infection numbers “mean something different now than they did a year ago,” Jha said. 

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) issued Valneva a list of questions about its vaccine candidate. Regulators are requesting additional data to justify a conditional marketing authorization for its inactivated COVID-19 vaccine candidate, VLA2001. Two weeks ago, the company was granted conditional marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K., following a March EUA from the Bahraini NHRA. Valneva expects an EMA authorization this quarter after it submits responses to the list of questions in the coming days. Thomas Lingelbach, Valneva CEO, commented that the company is “disappointed that the EMA has not considered our submissions sufficient to date,” noting that the vaccine candidate is the only inactivated COVID-19 candidate in Europe. 

UPDATED: Friday, April 22 at 9:20 a.m. ET

Novavax has started dosing patients in a phase 3 booster trial in teens ages 12 to 17. The study is looking at the safety and immunogenicity of a third dose of the company’s protein-based COVID-19 vaccine. Novavax filed its shot for an emergency use nod in the U.S. earlier this year. Elsewhere, the company’s vaccine has been cleared in places like the U.K., Australia and Europe.

The World Health Organization issued a “strong recommendation” for Pfizer’s oral antiviral Paxlovid, branding it the “best therapeutic choice for high-risk patients to date.” That said, availability, lack of price transparency, Pfizer’s supply deals, plus the need for “prompt and accurate testing” before administration mean the drug is posing “a major challenge for low- and middle-income countries,” WHO said.

Meanwhile, WHO updated its recommendation for Gilead Sciences’ remdesivir, also known as Veklury. The organization previously suggested patients use Gilead’s med regardless of disease severity. With new clinical data on tap, WHO suggests remdesivir use be restricted to mild or moderate COVID-19 patients at high risk of hospitalization.

Serum Institute of India, the world’s largest vaccine manufacturer by doses, has halted production of new COVID shot batches after accumulating a stockpile of 200 million doses, Bloomberg News reports, citing comments made by SII’s chief executive Adar Poonawalla at the India Economic Conclave organized by Times Network on Friday. Serum Institute’s production pause comes as vaccine oversupply creeps up around the world, Bloomberg noted.

Regeneron CEO Len Schleifer, M.D., Ph.D., took home 95% less pay in 2021 versus 2020. But the compensation slump shouldn’t come as a shock. Most of Schleifer’s 2020 pay was tied to a front-loaded equity award. Under that compensation plan, Regeneron’s CEO and its top scientist, George Yancopoulos, M.D., Ph.D., won’t be handed more stocks until December 2025. Schleifer took home a total of $6.47 million last year. Story

UPDATED: Thursday, April 21 at 10:14 a.m. ET

A U.K.-wide study found prolonged “strong immune responses” 84 days after participants received a booster COVID-19 shot. The study, led by the University Hospital Southampton (UHS) and published in the Journal of Infection, tested immune responses after seven different vaccines used as a boosters 28 days after receiving two doses of AstraZeneca or Pfizer vaccines. While different initial vaccines yielded different results from the booster, “the rate that immune cell responses declined after third doses was similar between all the vaccine combinations and doses,” according to a UHS spokeswoman quoted in the Evening Standard. The study also found that a half dose of Pfizer’s vaccine prompts similar responses to a full dose at three months, which could “help in planning global vaccine supply and delivery,” according to Saul Faust, a professor of pediatric immunology and infectious diseases at the University of Southampton and director of the NIHR Southampton Clinical Research Facility.

CureVac and GlaxoSmithKline announced positive preclinical data from a study demonstrating immune responses and efficacy of a COVID-19 vaccine candidate combining two mRNAs encoded for the Beta and Delta variants. The vaccine “significantly reduced” the viral load in animals tested. New vaccine strategies, such as combining several variant-specific mRNAs within one vaccine, can be “essential to take over the COVID-19 virus dynamic and set new standards for broadly effective vaccines against other infectious diseases,” Dr. Igor Spawski, Chief Scientific Officer of CureVac, said in a statement.

Noubar Afeyan, Moderna's chairman and co-founder, predicts that annual COVID-19 boosters will become the norm. In an appearance on Bloomberg Surveillance, Afeyan referred to COVID-19 as a “battle royale” between two life forms running defenses and offenses. To combat the virus, which has “a mind of its own,” fourth boosters should be taken by people who want to avoid infection, Afeyan said.

UPDATED: Wednesday, April 20 at 10:37 a.m. ET

Arcturus Therapeutics shared topline data from an ongoing clinical trial evaluating the company’s self-amplifying mRNA COVID-19 vaccine candidate. The positive results revealed 95% efficacy overall for prevention of severe COVID-19 and 55% efficacy for preventing symptomatic COVID-19, according to a new press release. The next step for the vaccine candidate is advancing toward a pivotal booster study.

Clover Biopharmaceuticals released data showing its vaccinate candidate would be the first and only option to provide significant protection to people who have previously been infected with the virus, the company said in a release.

Amid China’s biggest COVID-19 surge since the start of the pandemic, efficacy issues with the country’s two homegrown vaccines have risen along with the omicron outbreak. Scientists recommend that China’s Sinovac vaccine be boosted with a more effective shot, The Financial Times reports. A recent study from the University of Hong Kong found that people over 60 who received Sinovac’s shot were three times more likely to die from COVID-19 than those who received two doses of the Pfizer/BioNTech vaccine.

Oxford Biomedica shares sank 7% after the company warned its revenue will suffer as it pauses the manufacturing of AstraZeneca’s COVID vaccine, Yahoo Finance reports.

UPDATED: Tuesday, April 19 at 10:30 a.m. ET

Poland has pulled out of contractual commitments to purchase the Pfizer/BioNTech COVID-19 vaccine, Politico reports. Health Minister Adam Niedzielski cited oversupply and financial strains due to the country’s influx of refugees fleeing Ukraine. The government invoked a clause refusing to pay for or take deliveries of future doses after attempting to comprise with vaccine suppliers. 

Johnson & Johnson is suspending sales forecasts for its COVID-19 vaccine, a change from only a few months ago when it was predicting $3.5 billion from the shot. First-quarter earnings released today by the company noted global supply surplus and demand uncertainty led to the suspension of vaccine sales guidance. The vaccine brought the company $457 million in global sales during the first quarter, with $75 million coming from the U.S.

Takeda has received marketing and manufacturing approval from the Japan Ministry of Health, Labor and Welfare for recombinant protein-based COVID-19 vaccine Nuvaxovid. Distribution will begin as soon as possible, according to a new report from BioSpace. Novavax licensed and transferred its manufacturing technology to allow Takeda’s production of the vaccine at its Hikari facility. The approval was granted after Takeda’s new drug application submission which included positive interim results from a Phase 1/2 study in Japan.

UPDATED: Monday, April 18 at 10:05 a.m. ET

Bayer is facing a lawsuit from a former employee who claims he was fired for refusing to provide proof of COVID-19 vaccination, CBC reports. The employee, who is not named due to personal health information, worked at Bayer for 18 years and worked from home as a program manager both before and during the COVID-19 pandemic. According to the lawsuit, his employment contract did not mention an obligation to report vaccination status, despite Bayer’s January 2022 vaccination requirement. He is alleging that his employment was terminated without just cause. Bayer has not yet filed a statement of defense.

Ocugen and Bharat Biotech expanded their commercialization agreement for whole virus inactivated vaccine Covaxin to include Mexico.Covaxin is currently authorized for emergency use in more than 25 countries, and applications for pending use are pending in another 60 countries.

Novavax’s COVID-19 vaccine will be the fourth vaccine available in Japan once greenlighted, The Mainichi reported. The contract with the government includes supplies of 150 million doses, which will likely be used as booster shots. The vaccine’s mechanism differs from the country’s existing approved vaccines and is easy to transport and manage. Takeda applied for approval with the health ministry in December of 2021 and will be responsible for Novavax’s Japan vaccine distribution.

Johnson & Johnson’s one shot COVID-19 vaccine appears to prevent infections, hospitalizations and deaths as well as rival Pfizer/BioNTech and Moderna vaccines, Seeking Alpha reports, citing CDC data. The rates of infection in those who received J&J’s vaccine was ~18.8 per 100,000, whereas Pfizer and Moderna infection rates in those who received shots were ~31.6 and ~32.6 per 100,000, respectively. As of recent CDC data, J&J’s one shot has performed on par with rival vaccines in preventing COVID-19 mortality.

UPDATED: Friday, April 15 at 11:07 a.m. ET

The U.S. Food and Drug Administration issued an emergency use authorization for the InspectIR COVID-19 Breathalyzer, the first COVID-19 diagnostic test that can detect infection through breath samples. The device is about the size of a piece of carry on luggage and can provide results in less than three minutes, according to the FDA press release. InspectIR expects a production rate of approximately 100 instruments per week, which can each evaluate approximately 160 samples per day. The instruments will be used in doctors offices, hospitals, and testing sites.

A new study from the University of Virginia School of Medicine found that the antibodies generated by Pfizer’s COVID-19 vaccine rise slower and decline faster than those generated by the rival Moderna vaccine. The study also found that age of the vaccine recipient affected the antibody results for the Pfizer vaccine, with older recipients generating fewer antibodies than younger recipients. Age did not appear to be a factor in Moderna’s vaccine. The scientists found that while both vaccines are similar, there are differences in their formulation and mRNA levels, which could explain the difference in antibody responses between the two. However, both vaccines deliver peak levels of COVID-fighting antibodies.

Indian media and the country’s drug regulator have largely been mum on manufacturing issues surrounding Bharat Biotech’s vaccine Covaxin, which, while unclear, were severe enough for the World Health Organization to recently warn nations against obtaining the shot, Stat News reports. The plant behind WHO’s alert has a troubled past, as well, during which India’s Central Drugs Standard Control Organization (CDSCO) has at times “remained a mute spectator,” the publication said. The news outlet credited the silence to broad support behind Prime Minister Narendra Modi’s AatmaNirbhar policy, which broadly espouses economic self-reliance.

UPDATED: Thursday, April 14 at 9:15 a.m. ET

Pfizer and BioNTech announced positive results from a phase 2/3 trial evaluating the safety of a booster dose of their COVID-19 vaccine, Comirnaty, in children 5 through 11 years of age. Data demonstrated a strong immune response and no new safety signals. The next steps for Pfizer and BioNTech is submitting a request for Emergency Use Authorization of the booster in this age group, which the companies plan to do shortly.

Poorer nations have refused tens of millions of doses of the AstraZeneca COVID-19 vaccine, Vaxzevria, from the global vaccine sharing program COVAX, Reuters reports. Over 200 million doses were assigned to 61 less developed countries for six months through September, but many countries declined to receive nearly 35 million doses. A spokesperson for Gavi, speaking on behalf of COVAX, said that shelf-life preferences could not be met with available AstraZeneca supply. In contrast, requests for Johnson & Johnson and Pfizer vaccines were at 70 million and 40 million.

The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has granted conditional marketing authorization for Valneva’s whole virus COVID-19 vaccine in adults 18 to 50 years of age, according to a press release. CEO Thomas Lingelbach noted that the Valneva vaccine is the only inactivated whole virus COVID-19 vaccine approved in the UK, and this authorization could “pave the way for the availability of an alternative vaccine solution for the UK population.”

UPDATED: Wednesday, April 13 at 3:58 p.m. ET

Pfizer could develop a new vaccine that protects against various forms of COVID-19 as well as the omicron variant by fall, CEO Albert Bourla, Ph.D., said at a press conference held by the International Federation of Pharmaceutical Manufacturers & Associations. While it’s “easy to do something only against omicron,” it is more challenging for a vaccine to be effective against everything known so far, “so you don’t have two different vaccines for different variants,” Bourla said.

According to the latest estimates from the Centers for Disease Control and Prevention, omicron subvariant BA.2 was responsible for 86% of new COVID-19 cases nationwide last week, CNN reports. Despite the rising case numbers, U.S. hospitalizations are at record lows and continue to drop.  

People 50 years and older are now eligible to receive the additional booster shot, but the Centers for Disease Control and Prevention isn’t pushing them to get in line. Many vaccine experts say healthy people under 65 years old can wait. One reason for the delay is limited understanding of T cells, an attack cell of the immune system, The Wall Street Journal reports.