Enlarge / California Gov. Gavin Newsom talks with 7th grade students at James Denman Middle School on October 01, 2021 in San Francisco, California. (credit: Getty | Justin Sullivan )

California Governor Gavin Newsom on Friday announced that the state will add COVID-19 vaccines to the list of immunizations students are required to get to attend in-person public and private schools.

California is the first state to announce such plans. COVID-19 vaccines will join the ranks of vaccine for measles, mumps, polio, hepatitis B, pertussis, tetanus, and chicken pox, which are already required for school attendance.

The mandate isn't immediate. The requirement will not kick in until the vaccine is fully approved by the Food and Drug Administration for school aged children. As such, the requirement will be phased in by grade groups—grades 7 through 12 and K-6—and begin at the start of the school term following full FDA approval.

Enlarge / The US Food and Drug Administration in Silver Spring, Maryland. (credit: Getty | Xinhua News Agency )

Two top vaccine regulators have resigned from the Food and Drug Administration, revealing anger, frustration, and turmoil at the federal agency as it faces intensifying pressure to authorize COVID-19 vaccine booster shots and doses for children under the age of 12.

The two regulators leaving are Marion Gruber, director of the FDA’s Office of Vaccines Research and Review (OVRR), and OVRR Deputy Director Phil Krause. Gruber has been with the FDA for more than 30 years, and Krause has been at the agency for more than a decade.

Their resignations, first reported by pharmaceutical trade publication BioCentury , were apparently sparked by frustration that the Biden administration had overstepped the FDA in announcing plans to offer COVID-19 booster shots beginning on September 20. The pair also clashed with higher-up Peter Marks, who reportedly went along with the administration's plans. Marks is the director of the FDA's Center for Biologics Evaluation and Research (CBER), which includes the OVRR.

Enlarge / tablets of Ivermectin drugs in Tehatta, West Benga, India on 19 May on 2021. (credit: Getty | Nurphoto )

Amid the current delta-fueled wave of COVID-19, officials have noted a dangerous surge in the misuse of a deworming drug routinely used in livestock. The result is an uptick in calls to poison control centers, empty shelves in farming supply stores, and pleas from regulators.

In an attention-grabbing tweet over the weekend, the Food and Drug Administration wrote bluntly: "You are not a horse. You are not a cow. Seriously, y'all. Stop it."

The agency stressed that the drug, ivermectin, is not FDA-approved to treat or prevent COVID-19 and, so far, there is no evidence that it does either of those things. However, it can cause serious side effects and overdoses, which can be life-threatening, the agency warned. Overdoses can result in nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma, and even death.

Enlarge / With new data, we're able to expand vaccinations to ever-younger populations. (credit: Roberto Jimenez Mejias / Getty Images )

On Wednesday, the CDC's Advisory Committee on Immunization Practices recommended that the CDC approve the use of the Pfizer/BioNTech COVID-19 vaccine for the 12- to 15-year age group. The decision comes two days after the FDA granted an emergency use authorization for the same age group and will help the US further limit the pool of people who can spread infections or foster the evolution of new viral variants. Formal CDC approval could come quickly, given recent history.

Given the FDA's earlier decision, the move might seem anticlimactic. But having the FDA and CDC officially on the same page is reassuring, and several state-run vaccination programs are awaiting the CDC's OK before expanding into that age group. Private providers and insurance companies were also varied in their response to the FDA's decision and were waiting for the CDC.

The data that supported the approval was pretty decisive, as a small Phase III clinical trial of 2,260 adolescents saw 16 cases of COVID-19, with every single one occurring in the placebo group. Side effects were similar to those experienced by older people, with a brief period of flu-like symptoms. The committee was tasked with considering whether the benefits outweighed the risks; given the minor side effects and the increasingly obvious benefits of vaccination , it's not a surprise that the vote in favor of approval by the committee was 14 in favor, none opposing, and a single recusal. The CDC director, Rochelle Walensky, is overwhelmingly likely to follow the committee's recommendation, most likely before the day is over. (We'll update this story if and when this occurs.)

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb )

States will not receive shipments of Johnson & Johnson’s one-shot COVID-19 vaccine next week, according to a report by Politico .

White House officials told governors in a call Tuesday that there are no new doses available for order. It’s unclear if the federal government will be able to distribute doses through other channels, such as those that provide vaccines directly to pharmacies and community health centers.

The dried-up supply is just the latest trouble for Johnson & Johnson, which has consistently struggled to produce its vaccine in the US.

Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS )

The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced Monday evening .

In the announcement, acting FDA Commissioner Janet Woodcock called the authorization “a significant step in the fight against the COVID-19 pandemic” that will bring the country “closer to returning to a sense of normalcy and to ending the pandemic.”

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, echoed that sentiment. He called the ability to vaccinate children and teens “a critical step” in the fight against COVID-19.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews )

The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.

Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.

"We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters . “We’ll see what happens," he added, leaving open the possibility of future orders.