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COVID-19: Weekly Update (August 29, 2022)


Vaccine developers seek the US Food and Drug Administration (FDA) approval for booster shots targeting the Omicron variants BA.4/5. A new study shows the incubation period of COVID-19 disease is getting shorter with every new strain of the SARS-CoV-2 virus.

Last week COVID-19 deaths reached 1 million worldwide so far in 2022, the World Health Organization (WHO) announced. The WHO Director-General Tedros Adhanom Ghebreyesus asked all governments to strengthen their efforts to vaccinate all health workers, older people, and others at high risk.

According to the Centers for Disease Control and Prevention (CDC), the 7-day moving average of daily new cases in the US decreased by 6.7% compared with the previous week.

There is a 6.6% decrease in hospitalizations from the prior week, and deaths decreased by 11.6%.

As of August 25, 29.5% of counties were with a high COVID-19 Community Level, 42.9% of counties with a medium Community Level, and 27.6% of counties with a low Community Level.

The FDA authorized the Novavax vaccine

The FDA authorized the emergency use of the Novavax COVID-19 vaccine in adolescents aged 12 through 17. The new subunit vaccine, approved as a two-dose primary series, delivers 5 mcg of the fully formed spike protein along with an adjuvant that focuses the attention of the innate immune system on the spike antigen.

In the Phase 3 clinical trial, the vaccine achieved a clinical efficacy of 78.29% overall when the Delta variant was the predominant strain in the US. The most common side effects experienced after any dose of the vaccine were injection site pain/tenderness, headache, and fatigue or malaise.

A myocarditis signal was detected during the trial and in post-authorization use in other countries; young males are at the highest risk, most often within seven days after dose 2.

Seeking approval for booster shots

Vaccine developers Pfizer and Moderna submitted applications to the FDA for emergency use authorization of their updated bivalent COVID-19 vaccine boosters targeting the Omicron variants BA.4 and BA.5.

These strains are responsible for more than 90% of all new COVID-19 cases in the US, according to the Centers for Disease and Control (CDC) data.

Pfizer and BioNTech seek authorization for the vaccine in people 12 and older, while Moderna’s application covers adults ages 18 and older.

The applications stirred controversy because both companies only provided data from preclinical trials in mice and clinical trials of BA.1 Omicron-targeting bivalent booster candidates. However, both developers said Phase 2/3 clinical trials of the Omicron BA.4/BA.5-adapted bivalent vaccines are underway.

Although the data presented to the FDA indicated the boosters increased neutralizing antibody levels, it is uncertain what the clinical relevance is with respect to preventing severe disease, particularly among those who have recovered from Omicron.

CNBC sources say that the FDA plans to authorize updated booster shots by Labour Day, September 5.

COVID-19 incubation period gets shorter

Researchers from Peking University and Tsinghua University in Beijing analyzed data from 141 studies with 8112 patients and estimated that the incubation period of COVID-19 caused by different strains of SARS-CoV-2 virus is getting shorter.

A study published in the journal JAMA Network Open suggests that the average incubation period with the initial Alpha variant was 5.00 days, with the Beta variant — 4.50 days and the Delta — 4.41 days. The Omicron variant, now dominant in the US and globally, has an average incubation period of 3.42 days.

“The findings of this study suggest that SARS-CoV-2 has evolved and mutated continuously throughout the COVID-19 pandemic, producing variants with different enhanced transmission and virulence. Identifying the incubation period of different variants is a key factor in determining the isolation period,” the study authors say.

Up to 4 million people are out of work

More than two years since the beginning of the pandemic, 16.3 million working-age Americans aged 18 to 65 suffer from long COVID-19 today, according to the report by the Brookings Institution.

The report uses data from the latest Household Pulse Survey (HPS) by the US Census Bureau. The survey reveals that of those with long COVID-19, 2 to 4 million people are out of work due to the condition. The annual cost of those lost wages alone is $168 billion annually, nearly 1% of the total US gross domestic product.

The report says that if the true number of people out of work is closer to 4 million, that is a $230 billion cost.

Moderna is suing Pfizer

Moderna said it filed patent infringement lawsuits against Pfizer and its German partner BioNTech over mRNA COVID19 vaccine technology.

"Moderna believes that Pfizer and BioNTech's COVID-19 vaccine Comirnaty infringes patents Moderna filed between 2010 and 2016 covering Moderna's foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna's own mRNA COVID-19 vaccine, Spikevax. Pfizer and BioNTech copied this technology, without Moderna's permission, to make Comirnaty," says Moderna's press release.

BioNTech said in a statement that its work is original and the company "will vigorously defend against all allegations of patent infringement" as it remains "confident in its intellectual property."

Resources:

1. The World Health Organization. Media briefing on Ukraine, monkeypox, COVID-19 and other global health issues.

2. CDC. Covid Data Tracker Weekly Review.

3. Novavax. U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17.

4. Pfizer. Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine.

5. Moderna. MODERNA COMPLETES APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR EMERGENCY USE AUTHORIZATION OF OMICRON-TARGETING BIVALENT COVID-19 BOOSTER VACCINE, MRNA-1273.222.

6. CNBC. FDA plans to authorize bivalent boosters by Labor Day, sources say.

7. JAMA Network Open. Incubation Period of COVID-19 Caused by Unique SARS-CoV-2 Strains.

8. The Brookings Institution. New data shows long Covid is keeping as many as 4 million people out of work.

9. Moderna. MODERNA SUES PFIZER AND BIONTECH FOR INFRINGING PATENTS CENTRAL TO MODERNA'S INNOVATIVE MRNA TECHNOLOGY PLATFORM.

10. BioNTech. Statement on Patent Infringement Lawsuit Filed by Moderna.

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