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Pfizer Signs New $3.2 Billion COVID Vaccine Deal With U.S. Government

Reuters reported:

Pfizer Inc. (PFE.N) and partner BioNTech SE (22UAy.DE) said on Wednesday they signed a $3.2 billion deal with the U.S. government for 105 million doses of their COVID-19 vaccine, which could be delivered as soon as later this summer.

The deal includes supplies of a retooled Omicron-adapted vaccine, pending regulatory clearance, according to Pfizer. Drugmakers have been developing vaccines to target the Omicron variant that became dominant last winter.

The U.S. government also has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million, the companies said.

The new contract should boost 2022 vaccine sales for Pfizer and BioNTech, which share profits from the shots. Pfizer has forecast COVID-19 vaccine sales of $32 billion this year. Analysts, on average, have forecast 2022 sales of around $33.6 billion for the shots.

Vaccines — Not Just COVID Shots — Linked to Type 1 Diabetes Because of Damage to These Types of Cells

The Epoch Times reported:

Since early 2021, the Beta Cell Foundation has collected data on vaccine adverse events from 528 patients with type 1 diabetes by using an online database for analysis.

The analysis showed that some patients with type 1 diabetes experienced elevated (or disturbed) blood glucose levels after vaccination with COVID vaccines.

What is the link between type 1 diabetes, COVID and the vaccines?

Omicron-Based Coronavirus Booster Shots Will Roll out This Fall

The Washington Post reported:

This fall, vaccine makers will begin rolling out coronavirus booster vaccines tailored to fight the current phase of the pandemic.

Two days after outside experts voted in favor of a new vaccine adapted to protect against Omicron, the Food and Drug Administration announced that the fall shots would include a component from BA.4 and BA.5, the Omicron subvariants gaining ground in the United States.

The change shows the FDA trying to be more nimble in efforts to keep up with a changing virus. The precise formula has not been tested in people yet, but studies showed that vaccines tuned to fight a previous version of Omicron modestly increased the short-term immune response in people compared with more shots of the original. The agency will depend in part on that data as it reviews the new vaccines.

It is quite possible that BA.4 and BA.5 will be eclipsed by new variants by the fall, but the hope is that a new shot will help broaden immunity since they are closer to where the virus is today.

FDA: Don’t Rush a Move to Change the COVID Vaccine Composition

STAT News reported:

On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2 to approve the use later this year of COVID-19 vaccines based on an Omicron variant sequence. One of us (P.A.O.) was among those voting “no.” It is possible these vaccines will be two-component designs that also include the current version. Will Americans soon be better protected against COVID-19?

The COVID-19 vaccines currently authorized for use in the U.S. are all based on the sequence of the original SARS-CoV-2 virus, which was obtained early in 2020. The virus has evolved over the past 30 months, creating variants that are either more infectious, harder to counter by vaccination or both.

Moderna and Pfizer executives have claimed that the Omicron vaccines will be protective for longer. That may be true, but how long is longer? A few weeks? A month or two? Again, detailed modeling of the data might provide important information. It’s important to be sure that changing the booster vaccine to include the Omicron sequence offers enough of an advantage to justify the cost and complexity associated with making the switch.

Pfizer Asks for Formal U.S. Approval of Oral COVID Treatment Paxlovid

Reuters reported:

Pfizer Inc. (PFE.N) said on Thursday it is seeking full U.S. approval for its oral COVID-19 antiviral treatment Paxlovid, which is currently available under an emergency use authorization (EUA).

Pfizer said it submitted a New Drug Application for Paxlovid to the Food and Drug Administration for the treatment of COVID-19 in vaccinated and unvaccinated people at high risk for progression to severe illness.

Bad News for Paxlovid? Coronavirus Can Find Multiple Ways to Evade COVID Drug

Science reported:

Prescriptions for Pfizer’s blockbuster drug Paxlovid have skyrocketed in recent weeks. That’s good news for many COVID-19 patients, as the pill has been proven to reduce severe disease from SARS-CoV-2 infections.

But a bevy of new lab studies shows the coronavirus can mutate in ways that make it less susceptible to the drug, by far the most widely used of the two oral antiviral drugs authorized to treat COVID-19 in the United States. Researchers have found some of those mutations in variants already circulating in infected people, raising fresh concerns that physicians could soon lose one of their best therapies for fighting COVID-19.

Taken together, the studies show that “when you put pressure on the virus it escapes,” says David Ho, a virologist at Columbia University who was among the first to document drug resistance mutations in HIV some 3 decades ago. Ho was not involved with the new studies but is conducting similar work on SARS-CoV-2. Although the newly identified mutations have yet to become widespread, Ho and many other scientists think it’s only a matter of time. “Given the amount of infections out there, it’s going to come,” Ho says.

The resistance studies come on the heels of other recent concerns about Paxlovid, which in the United States remains restricted to use in people with risk factors making them more likely to develop severe COVID-19.

‘Moderate’ Vax Protection Against Omicron for Young Kids — Vaccine Effectiveness Lower Among the Older Kids in the 5-11 Group

MedPage Today reported:

Protection against Omicron in children ages 5-11 years was minimal following a single dose of Pfizer/BioNTech’s COVID-19 vaccine, but hovered around 50% following the second dose, a large observational study from Israel found.

In the 14 to 27 days after the first dose of BNT162b2, vaccine effectiveness (VE) against Omicron was 17% for a documented infection (95% CI 7-25) and 18% for a symptomatic case (95% CI -2 to 34), reported Noa Dagan, MD, Ph.D., of the Clalit Research Institute in Tel Aviv, and colleagues.

WHO: COVID Cases Rising Nearly Everywhere in the World

Associated Press reported:

The number of new coronavirus cases rose by 18% in the last week, with more than 4.1 million cases reported globally, according to the World Health Organization.

The U.N. health agency said in its latest weekly report on the pandemic that the worldwide number of deaths remained relatively similar to the week before, at about 8,500. COVID-related deaths increased in three regions: the Middle East, Southeast Asia and the Americas.

The biggest weekly rise in new COVID-19 cases was seen in the Middle East, where they increased by 47%, according to the report released late Wednesday. Infections rose by about 32% in Europe and Southeast Asia, and by about 14% in the Americas, WHO said.

WHO Director-General Tedros Adhanom Ghebreyesus said cases were on the rise in 110 countries, mostly driven by the Omicron variants BA.4 and BA.5.

France’s New Wave of COVID Infections Expected to Peak End-July — Scientist

Reuters reported:

A new wave in France of COVID-19 infections fueled by emerging variants of the disease should peak towards end-July, the French government’s top scientific adviser Jean-Francois Delfraissy said on Thursday.

“The peak is not yet here, this peak of infections will probably be for end-July,” Delfraissy told RTL radio. “Then the BA.5 variant will reappear if it is not overtaken by another variant … in autumn,” he added.

The French government also recommended this week that people should start wearing face masks again in crowded areas, especially in public transport, to counter the latest surge in COVID cases.