COVID-19 tracker: Pfizer pads Prevnar co-administration case; FDA flags side effect risk after Johnson & Johnson shot

Pfizer debuted data to support co-administration of a COVID-19 booster with its pneumococcal conjugate shot Prevnar 20. 

The FDA updated its fact sheet for Johnson & Johnson’s vaccine to cite the risk of immune thrombocytopenia. 

Novavax sees three areas of demand for its vaccine in 2022. Meanwhile, the company’s protein-based shot just won approval in South Korea. 

The worldwide case count surpassed 313 million as of Wednesday morning, with 5.5 million reported deaths, according to Johns Hopkins University’s COVID-19 dashboard.

Please read below for the latest updates. Daily COVID-19 tracker entries from Nov. 30 to Dec. 22 can be found here. April 29 to Nov. 29 can be found here. Daily entries from Nov. 2, 2020, to April 28 can be found here.

UPDATED: Wednesday, Jan. 12 at 9:00 a.m. ET

A booster dose of Pfizer’s COVID-19 vaccine works alongside its pneumococcal conjugate shot Prevnar 20, the company said Wednesday. Prevnar 20 immune responses were “similar” whether patients also received the drugmaker’s mRNA vaccine or placebo, and the same was true of immune responses from the COVID-19 vaccine. The safety of the co-administration regimen “generally reflected that observed with the Pfizer-BioNTech COVID-19 vaccine booster dose,” the company said. Pfizer ran its co-administration study in 570 adults ages 65 and older. Release

The FDA revised the fact sheet for Johnson & Johnson’s vaccine to cite the “serious risk” of immune thrombocytopenia (ITP), which can cause easy or excessive bruising and bleeding. Specifically, it includes information about side effect reports after vaccination with the J&J shot that “suggest an increased risk of ITP during the 42 days following vaccination.” The FDA urged patients with a history of ITP to weigh the risk and the potential need for platelet monitoring post-vaccination. Release

South Korea gave a thumbs up to Novavax’s protein-based vaccine in people ages 18 and older. The shot, which will be marketed in the country as Nuvaxovid, will be manufactured and sold by Novavax’s partner SK bioscience. SK has inked an advance purchase agreement with South Korea for 40 million doses. Release

Meanwhile, Novavax expects demand for its vaccine to play out globally across all three key areas: primary vaccination, booster doses and the pediatric market, Silvia Taylor, senior vice president, global corporate affairs and investor relations at Novavax, said in an interview. There are currently some 5 billion “doses of demand” in the high-income market alone, Taylor said. Moving into middle- and lower-income countries, demand jumps to more than 6.5 billion, she added. On the booster front, Novavax’s shot is enrolled in studies assessing so-called heterologous boosting, when a person receives one vaccine to start and gets boosted with another. Story

UPDATED: Tuesday, Jan. 11 at 9:40 a.m. ET

GlaxoSmithKline and Vir Biotechnology will supply an additional 600,000 doses of their COVID-19 antibody treatment, sotrovimab, to the U.S., the companies announced. Delivery is scheduled for the first quarter of this year. While some other antibody treatments have shown to be ineffective against the omicron variant, sotrovimab retains its effectiveness against. The agreement brings the companies’ total supply to the U.S. to 1.7 million doses. Tuesday’s agreement comes with an option for the U.S. to buy additional doses in the second quarter.

BioNTech and InstaDeep have developed a system that uses modeling of the spike protein and artificial intelligence to predict new high-risk variants using virus sequencing data. The Early Warning System, as it has been dubbed, assesses the immune escape and fitness metrics of newly identified variants. High-risk variants can be flagged in less than a day. In a trial, the system identified more than 90% of the WHO-designated variants by an average of two months in advance. The EWS detected omicron on the day its sequence was first uploaded. It was identified as the highest immune escaping variant from over more than 70,000 variants discovered from early October to late November.

One booster dose of CanSino Biologics’ inhaled COVID-19 vaccine, Inhalation Convidecia, for those who have received two doses of an inactivated COVID-19 vaccine can induce a higher level of neutralizing antibodies than a homogeneous booster of inactivated vaccine, a study showed. The inhaled vaccine provides unique advantages, training the immune memory function of the body by imitating the natural infection of the virus.

Adamis Pharmaceuticals is seeking fast-track designation from the FDA for Tempol, its oral drug to treat and prevent COVID-19. Touting Tempol’s anti-inflammatory and antiviral effects, the company says it could fulfil an unmet need. Patients in a phase 2/3 trial of the drug were dosed starting in September of last year.

Pfizer has bumped up its estimate for production of its COVID-19 antiviral pill Paxlovid. During the J.P. Morgan Healthcare Conference, CEO Albert Bourla said the company plans to manufacture 120 million courses of the treatment this year, which works out to 3.6 billion tablets. Boula also said that the figure could grow as countries have expressed an interest in stockpiling the drug which has a three-year shelf life. In early November, Pfizer said it planned to produce 50 million courses of the treatment. Later in the month, the company boosted the estimate to 80 million. Story.

UPDATED: Monday, Jan. 10 at 9:16 a.m. ET

While COVID-19 antibody sales didn’t match up to mRNA vaccine revenues in 2021, they contributed a welcome boost to the toplines at companies such as Regeneron. The New York-based biotech reported unaudited sales of $2.29 billion for its Regen-Cov combo in the fourth quarter, bringing the drug’s annual haul to nearly $6 billion.

Speaking at the virtual J.P. Morgan Healthcare Conference on Monday, Moderna CEO Stéphane Bancel said that he expects people 50 and older, plus the immunocompromised and others, may need annual COVID booster doses.

The United States’ latest surge in cases could peak later this month, Dr. Ashish Jha, dean of the Brown University School of Public Health, said on ABC’s « This Week. » But the surge in cases comes as many hospitals face critical staffing shortages, CNN reports.

In some places, hospitals are being forced to leave beds empty in response to staffing shortages, The Wall Street Journal reports. That’s considered a last resort for hospital administrators to maintain quality of care with the staff they have, according to the newspaper.

UPDATED: Friday, Jan. 7 at 8:20 a.m. ET

A single shot of the Johnson & Johnson COVID-19 vaccine offered protection for up to six months against COVID-19 hospitalizations, according to results from a real-world study, the company said. By comparison, mRNA vaccines by Pfizer-BioNTech and Moderna showed waning effects in months 2 and 3, respectively. The study analyzed records from 168 million vaccinated people last year between Jan. 1 and Sept. 7. Release

Rather than 500 pages per month as the FDA has requested, the agency must process and release 55,000 pages of documents it used to approve Pfizer and BioNTech‘s Comirnaty per month, a federal judge in Texas has ruled. The group is asking for altogether 450,000 pages of documents, which now means the FDA has about eight months to meet the FOIA request, Reuters reported.

Researchers have launched a trial in South Africa among health workers to compare Johnson & Johnson‘s and Pfizer-BioNTech‘s COVID shots as boosters, Bloomberg reported.

The CDC has relaxed its quarantine and isolation guidance for K-12 schools, The Wall Street Journal reported. Students can leave isolation five days after their initial positive test or the onset of symptoms, or if they are fever-free for 24 hours without the effect of fever reducer and their symptoms have improved.

UPDATED: Thursday, Jan. 6 at 9:20 a.m. ET

Pfizer has amended a clinical trial of its COVID vaccine in kids under the age of 5 to give a third dose to everybody at least eight weeks after their last dose, a Pfizer vaccine researcher said at a meeting of the CDC‘s Advisory Committee on Immunization Practices, Reuters reported. The company now expects to have data from the group in April.

Gavi, the Vaccine Alliance is in talks with Bharat Biotech for potential procurement of the latter’s Covaxin for the COVAX vaccine distribution program, a Gavi spokesperson reportedly told Reuters. About 180 million Covaxin doses have been administered in India, plus another 3 million doses have been exported or donated. 

Gritstone bio has unveiled early data for its self-amplifying mRNA vaccine. In one cohort of the phase 1 CORAL-BOOST trial, a single dose of the shot as a booster triggered strong antibody and T-cell responses in ten healthy adults 60 or older who had received two prior doses of AstraZeneca’s COVID-19 vaccine. Release

The CDC followed up an FDA expanded authorization with a recommendation that adolescents age 12 to 17 should receive a Pfizer-BioNTech booster shot five months after their primary vaccinations. Release

UPDATED: Wednesday, Jan. 5 at 9 a.m. ET

The Biden administration doubled its order of Pfizer’s COVID antiviral, Paxlovid, bringing the total to 20 million courses. The U.S. government also aims to accelerate the delivery, with all doses expected to be shipped by September. Story

Meanwhile, India refused to include Merck’s COVID pill, molnupiravir, in its national treatment guideline out of « major safety concerns, » a senior health official told a media briefing, as quoted by Reuters.

A fourth shot of Pfizer and BioNTech’s Comirnaty vaccine, given around five months after the third dose, triggered a fivefold increase in blood antibodies one week after the injection, according to data from Israel’s Sheba Medical Center, The Wall Street Journal reported. The finding came from a study in 154 medical workers.

The FDA halted manufacturing site inspections through Jan. 19 to cope with the threat of omicron. But the agency said it intends to continue conducting « mission-critical » domestic and foreign inspections. Release

NRx Pharmaceuticals refiled an application for FDA emergency use authorization of anti-inflammation drug Zyesami. The FDA last year rejected the drug. This time, the company is asking for a narrower indication in treating critical COVID patients at an immediate risk of death who were previously treated with Gilead Sciences’ remdesivir. Release

Shionogi has delayed a Japanese filing of its COVID pill, dubbed S-217622. The company was originally targeting a go-ahead by the end of 2021, but enrollment in a local phase 2/3 trial that started in September was slower than expected, news agency Jiji Press reported.

UPDATED: Tuesday, Jan. 4 at 10 a.m. ET

The FDA has expanded the emergency use authorization for a booster dose of Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty, to cover adolescents 12 to 15 years of age. Meanwhile, the FDA reduced the interval before an individual can receive a booster dose after the primary series. It’s now five months instead of the previous six months. Release

A booster shot of Johnson & Johnson’s COVID vaccine was 85% effective against COVID-related hospitalization, a phase 3b study showed. The trial was conducted in South Africa in late 2021, when omicron was the dominant coronavirus variant in the region. Separately, another study from Beth Israel Deaconess Medical Center examined blood from 65 vaccinated individuals. The researchers recorded a marked increase in both neutralizing antibody and T-cell response for the J&J shot given as a booster after Comirnaty. Release

After much delay, Novavax filed the data on its COVID-19 vaccine’s manufacturing process to the FDA on the last day of 2021. That completes its data package for NVX-CoV2373, but a formal request for an emergency use authorization won’t happen until a month later. Release

Robust activation of immune cells known as T follicular helper cells, which can last for up to six months, might explain why Comirnaty works so well against severe COVID, a new study published in the journal Cell shows. Story

India’s Dr. Reddy’s Laboratories will sell its generic version of Merck’s COVID antiviral molnupiravir at 35 rupees ($0.50) per capsule, Reuters reported. That adds up to about $20 for a five-day treatment course of 40 capsules. By comparison, Merck is selling the drug to the U.S. government at about $700 per course.