Moderna Asks FDA to Authorize Second Booster for COVID

Brett SmithMarch 22, 2022

Monday, March 21, 2022

FDA Puts Out Its Most Serious Recall for 2 Rapid Tests

The U.S. Food and Drug Administration (FDA) has issued class 1 recalls on two rapid home COVID-19 tests. This is the agency’s most serious type of product recall. One of the products, the SD Biosensor STANDARD Q COVID-19 Ag Home Test (which uses a nasal swab sample to detect proteins called antigens from the coronavirus) has been taken off the market because it has not been authorized, cleared, or approved by the FDA for marketing or distribution in the United States. The other — the Celltrion DiaTrust COVID-19 Ag Rapid Test — has been pulled due to it producing a high number of false positives and because of incorrect labeling that says its shelf life is 18 months instead of the approved 12 months. The Celltrion test is intended to detect the presence of coronavirus based on a nasopharyngeal (deep inside the nose to the back of the throat) swab sample.

35 Drugmakers to Make Generic Version of Oral Antiviral Paxlovid

Approved by the FDA in December, Pfizer’s oral antiviral Paxlovid (nirmatrelvir and ritonavir) has been shown to be 90 percent effective at reducing the risk of hospitalization or death in high-risk patients with COVID-19. The United Nations (U.N.)–backed Medicines Patent Pool (MPP) announced last week that 35 pharmaceutical companies around the world will now produce cheap generic version of the medication, according to Reuters. The deal coordinated by Pfizer will allow the drug manufacturers to make the pills for 95 low- and middle-income countries.

CDC Relaxes COVID-19 Protocols for Cruise Ships

As reported by USA Today, the Centers for Disease Control and Prevention (CDC) on Friday published updated voluntary guidelines for cruise ships relaxing physical distancing requirements for shore excursions and transportation, allowing cruises to resume approved “passenger interactive experiences,” and changing quarantine policy based on vaccination status. If a traveler identified as a close contact is disembarking the ship within 36 hours, the cruise ship operator may allow the traveler to stay in the original cabin if the traveler will be the only person in that cabin. USA Today said that although the cruise guidelines program is voluntary, 110 cruise ships participate. The CDC also lowered its risk assessment of taking a cruise from level 3 to level 2, or “moderate risk.”

Vaccines Offer Strong Protection — Even During Omicron

Adults who received three doses of either the Pfizer or Moderna vaccine were 94 percent less likely to to be put on a ventilator or die from COVID-19 compared with adults who were not vaccinated, a report published March 18 in the CDC’s Morbidity and Mortality Weekly Report shows. Based on cases reported at 21 hospitals across 18 states between March 11, 2021, and January 24, 2022, the research noted that protection was consistent throughout the delta and omicron periods. Most vaccinated patients who experienced COVID-associated invasive mechanical ventilation or who died in a hospital were older or had complex underlying conditions, commonly immunosuppression.

Black Americans Hospitalized at 4 Times Rate of White Americans When Omicron Dominated

In January, when omicron circulation peaked, hospitalization rates among Black adults were nearly 4 times higher than the rates among white adults, according to data published by the CDC March 18 in the Morbidity and Mortality Weekly Report. As of January 26, 2022, 39.6 percent of Black persons received a primary vaccine series; of those, 43.9 percent of adults received a booster dose. These proportions are lower compared with 47.3 percent of white persons who received a primary series and 54.5 percent of eligible adults who received a booster dose. The report also highlighted that unvaccinated adults were 12 times more likely to be hospitalized than individuals who had their primary shots and were boosted, and those who had the primary two-dose vaccine but no booster were 3 times as likely to be hospitalized compared with the boosted. “Implementing strategies that result in the equitable receipt of COVID-19 vaccinations, though building vaccine confidence, raising awareness of the benefits of vaccination, and removing barriers to vaccination access among persons with disproportionately higher hospitalizations rates from COVID-19, including Black adults, is an urgent public health priority,” concluded the study authors.

Johnson & Johnson Vaccine Recipients Had Lowest Breakthrough Rate

Based on the latest five weeks of available data from the CDC, CNN has found that the J&J vaccine had the lowest breakthrough infection rate of all the vaccines since the week ending December 25. Analysis by the news service revealed that, as of the week ending January 22, J&J recipients had 650 infections per 100,000 people, while Moderna recipients had 750 per 100,000 and Pfizer people had 862 per 100,000. The report also spotlighted an investigation published in JAMA Open Network March 17, showing that the J&J shot was 76 percent effective overall in blocking infections and 81 percent effective in preventing COVID-related hospitalizations.

Severe COVID-19 Linked to Long-Term Depression

As reported by the Center for Infectious Disease Research and Policy, a new observational study in six European countries, published March 14 in The Lancet Public Health, ties severe COVID-19 to long-term depression. Scientists analyzed outcomes among nearly a quarter-million individuals — 9,979 who received a COVID-19 diagnosis. Those with COVID-19 had a higher prevalence of depression symptoms and poorer sleep quality but not symptoms of anxiety compared with individuals without COVID-19. Patients who were bedridden for more than seven days were persistently at higher risk of symptoms of depression and anxiety than those without the virus.

Friday, March 18, 2022

Moderna Seeks Authorization for Second Booster

Moderna announced that it has submitted a request to the FDA for an amendment to the emergency use authorization (EUA) to allow for a fourth dose of its COVID-19 vaccine in people 18 years of age and older who have received an initial booster of any of the authorized or approved vaccines.

WHO Calls Recent Rise in Global COVID-19 Cases ‘Tip of the Iceberg’

As NBC News reported, the World Health Organization (WHO) warned countries to remain vigilant as infections in Asia and Europe have been climbing. Tedros Adhanom Ghebreyesus, PhD, Director-General of the WHO, told reporters, “these increases are occurring despite reductions in testing in some countries, which means the cases we’re seeing are just the tip of the iceberg.” Public health authorities attribute increasing case counts to the highly transmissible omicron subvariant BA.2 and the elimination of COVID-19 restrictions by many countries.

Most COVID-19 Patients Later Suffer Memory and Concentration Problems

The Center for Infectious Disease Research and Policy on Thursday shared details from new research published in Frontiers in Aging Neuroscience finding that 70 percent of 181 adult coronavirus survivors experienced issues with memory and concentration. Three-quarters had such severe effects that they were unable to work. Scientists noted that “brain fog and difficulty concentrating are more common than cough is at many points in the long COVID time course.”

Canada Okays Moderna’s Vaccine for Younger Children

Canada authorized the use of the Moderna Spikevax COVID-19 vaccine in children 6 to 11 years old. The decision comes about four months after the country greenlighted the Pfizer vaccine for use in this younger age group. In the United States, the Pfizer shot is the only coronavirus vaccine approved for children ages 5 to 17. Moderna has conducted clinical trials showing that its vaccine produces a robust neutralizing antibody response. But so far, its shot is only authorized in the United States for those ages 17 and up.

South Korea Breaks Infection Record

Reuters reported that South Korea tallied a record 621,328 new daily COVID-19 cases and a daily high of 429 deaths on Thursday, surpassing its second deadliest day on Tuesday when 293 coronavirus fatalities were recorded. A public survey revealed that many South Koreans expect to catch the virus, but few fear serious health consequences.

Hong Kong Increases Mortuary Capacity as Bodies Pile Up

The government of Hong Kong announced in a press release on Thursday that it has adopted various measures to expand body storage capacity and speed up the procedure for identification of bodies, in order to handle the increasing number of deceased bodies in public mortuaries. The BMJ on March 17 said that Hong Kong currently has the world’s highest death rate, above 25 per 100,000 residents. Government officials point to an elderly population that is largely unvaccinated as a contributing factor.

Evidence Mounts Linking COVID-19 to Diabetes

A report from the Associated Press reviewed emerging data indicating that the coronavirus — like some other viruses — can attack insulin-producing cells in the pancreas — a process that might trigger at least temporary diabetes in susceptible people.

Thursday, March 17, 2022, 1:20 P.M. EDT

Omicron Subvariant BA.2 Accounts for Nearly One-Quarter of New Cases

BA.2, a subvariant of the omicron variant of COVID-19, now makes up 23 percent of infections in the United States, according to latest data from the CDC. The increase is more than double from a week ago. In an article from CBS News, Deborah Dowell, MD, MPH, the CDC’s chief medical officer for the agency’s COVID-19 response, said, “Although the proportion of infections with BA.2 is increasing in the U.S., COVID-19 cases are now declining, so it is likely that absolute numbers of BA.2 infections are not increasing as quickly as they might seem from just looking at the proportion that are BA.2.”

CDC Data Shows Rise of COVID-19 in Wastewater

Analysis of CDC data by Bloomberg on Monday indicates that coronavirus levels in the wastewater are climbing in several parts of the United States. One-third of the agency’s wastewater sample sites shows a rise from March 1 to 10. The number of sites with swelling virus levels is almost double from the period February 1 to 10. In an email to Bloomberg, Amy Kirby, PhD, MPH, the head of the CDC’s wastewater monitoring program, said, “While wastewater levels are generally very low across the board, we are seeing an uptick of sites reporting an increase. These bumps may simply reflect minor increases from very low levels to still low levels.”

She added, however, that some communities may see an increase in infections as many states have recently dropped COVID-19 restrictions.

Surge in Western Europe Puts U.S. Health Officials on the Alert

In an investigation by the Washington Post published Wednesday, health authorities say they are bracing for another COVID-19 wave in the United States based on the current upswing in infections in Europe. Germany, Britain, and the Netherlands have all recorded a significant rise in cases in recent days.

Biden Cancels Face-to-Face Meetings After Ireland’s PM Tests Positive

President Biden canceled in-person meetings with Prime Minister Micheal Martin of Ireland today because the prime minister tested positive at a gala event last night, as reported by The New York Times. Biden was also in attendance at the event.

South Korea Has Deadliest Day

South Korea recorded 293 deaths due to the coronavirus in a 24-hour period on Tuesday — the country’s highest single-day total since the start of the pandemic, the Associated Press reported. The number of virus patients who are seriously or critically ill also hit a new high of 1,196. Health officials blame the uptick on the fast-spreading omicron variant and they expect the strain on the country’s hospital system to increase in coming weeks.

Biden’s COVID-19 Czar Stepping Down and Successor Named

White House COVID-19 response coordinator Jeffrey D. Zients plans to leave his post in April and will be replaced by Ashish Jha, MD, MPH, dean of the Brown University School of Public Health.

Jeffrey D. Zients, who steered President Biden’s coronavirus response through successive pandemic waves and the largest vaccination campaign in American history, plans to leave the White House in April, President Biden said in a statement.

A Link Between COVID-19 Death and Internet Access?

An article published Wednesday by Vox highlighted results from a study published March 4 in JAMA Network Open suggesting that that one of the factors most consistently associated with a high risk of death due to COVID-19 in the United States was the lack of internet access, whether broadband, dial-up, or cellular. “We believe this finding suggests that more awareness is needed about the essential asset of technological access to reliable information, remote work, schooling opportunities, resource purchasing, and/or social community,” wrote investigators. “Populations with limited internet access remain understudied and are often excluded in pandemic research.”

Rise in Croup Among Kids Tied to Omicron

A study published March 8 in Pediatrics, the official journal of the American Academy of Pediatrics, found that the incidence of croup co-occurring with coronavirus infection sharply increased in December 2021, strongly connecting it with the emergence of the omicron variant. The results were based on children admitted with COVID-19 to Boston Children’s Hospital. “The relatively smaller upper respiratory tract in children compared with adults has been thought to predispose them to more severe clinical presentations resembling laryngotracheobronchitis, or croup [an infection of the upper airway characterized by a barking cough],” wrote the authors.

Reinfection Was More Likely During Omicron Wave

Based on surveillance data, researchers in South Africa observed that an increased risk of reinfection coincided with the emergence of the omicron variant in that country, according to a paper published Tuesday in the journal Science. They did not find any evidence, however, of increased reinfection risk associated with circulation of beta (B.1.351) or delta (B.1.617.2) variants.

Wednesday, March 16, 2022, 2:06 P.M. EDT

Pfizer Seeks FDA Okay of 4th Shot for People 65 and Older

Pfizer and BioNTech announced on Tuesday that they have submitted an application to the FDA for emergency use authorization (EUA) of an additional booster dose for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. The submission was based on two studies out of Israel during the omicron wave that demonstrated a fourth shot boosts the body’s immune response and provides a higher rate of protection against infection and severe illness.

Albert Bourla, CEO of Pfizer, told Face the Nation on Sunday, “Right now, the way that we have seen, it is necessary, a fourth booster right now. The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, but doesn’t last very long. But we are just submitting those data to the FDA and then we will see what the experts also will say outside Pfizer.”

Pfizer Stops Clinical Trials in Russia

Pfizer said on Monday that it would no longer initiate new clinical trials in Russia, and will stop recruiting new patients for its ongoing clinical trials there, according to The Hill. The pharmaceutical giant said that it will donate all the profits from its Russian subsidiary to programs that provide direct humanitarian support to the people of Ukraine.

China Locks Down City of 17.5 Million as Cases Triple

As reported by The Guardian, the Chinese city of Shenzhen, with a population of 17.5 million, went into lockdown on Sunday as China tries to contain its worst ever outbreak. Government figures show that case numbers tripled between Saturday and Sunday. Every resident in Shenzhen is now required to be tested three times.

Rethinking Goal of Vaccinating 70 Percent of Adults

The WHO and the U.S. government have been promoting a goal of vaccinating 70 percent of all adults regardless of age. In interviews with NPR, scientists said that a new strategy that prioritizes people over 50 may be smarter at this stage. Shabir Madhi, MBBCh, PhD, a prominent vaccine researcher at South Africa’s University of Witwatersrand, told NPR, “We seem to have lost perspective as to what the major goal of vaccines is and where they are going to yield the greatest public health benefit.”

Merck’s Antiviral Extensively Used Despite Lower Effectiveness

Clinical trials have indicated that the antiviral pill Paxlovid from Pfizer is about 70 percent effective in preventing severe illness in the newly infected compared with molnupiravir (developed by Merck and Ridgeback), which is about 30 percent effective. An investigation by The Wall Street Journal found that both pills have been prescribed at almost equal rates since they were authorized in December 2021. Doctors told the Journal that they often turned to molnupiravir, especially during the recent omicron surge, because Paxlovid supplies were limited.

1 in 4 Kids With Symptomatic Infections Had Long COVID

A preprint systematic review posted to medRxiv of 21 studies regarding long COVID in children and adolescents revealed that one-quarter of U.S. children with symptomatic infections had long COVID, with negative health consequences lasting weeks to months after contracting the virus. The most prevalent long COVID conditions were mood symptoms, fatigue, and sleep disorders.

Second Gentleman Doug Emhoff Tests Positive

Doug Emhoff, the husband of vice president Kamala Harris, tested positive for COVID-19 on Tuesday, according to a statement from the Deputy Press Secretary to the Vice President, Sabrina Singh. Out of an abundance of caution, Harris (who tested negative) did not attend an event on Equal Pay Day to celebrate Women’s History Month.

Tuesday, March 15, 2022

Some States Resist Sewage Monitoring for COVID-19

Based on interviews with state health officials and wastewater experts across 17 states, Politico found that many states are not on board with the Biden administration’s plans to monitor sewage for signs of the coronavirus. Testing wastewater can give an early warning when an outbreak is starting to grow. California, Florida, Texas, and Pennsylvania have a few testing sites in operation near major population centers; Minnesota and New Jersey have yet to determine how their monitoring will work; and Wyoming and North Dakota don’t intend to participate.

1 in 3 U.S. Child COVID-19 Deaths Were During Omicron Wave

The Guardian presented data from the CDC showing that 550 American children have died from the coronavirus since the beginning of the year, compared with 1,017 kids in the previous 22 months. The Guardian said that children seem to be facing increasing risks as mask mandates are abandoned and vaccination rates stall. Jason Kane, MD, associate professor of pediatrics at the University of Chicago Comer Children’s Hospital, told the paper, “We saw a massive surge of hospitalized young children during omicron that we didn’t see in the earlier months of the pandemic.”

Costco Ending Pandemic Shopping Hours for Seniors

Costco announced that as of April 18 it will no longer be offering special shopping hours for members ages 60 or older, healthcare workers, and first responders. Members who do not wish to shop during regular hours are welcome to visit Costco.com for all their shopping needs. Costco had implemented the special shopping hours in March of 2020 to help protect those most at risk of contracting severe illness from the coronavirus.

U.K. Will Drop Remaining COVID-19 Travel Measures

As reported by USA Today, the United Kingdom this week plans to eliminate international travel restrictions allowing all those coming from abroad to enter the country without a passenger locator form or a negative coronavirus test. The new policy goes into effect 4 a.m. this Friday.

3 House Democrats Test Positive After Party Retreat

Despite being vaccinated and boosted, Representatives Madeleine Dean of Pennsylvania, Zoe Lofgren of California, and Rose DeLauro of Connecticut have all revealed that they have tested positive for COVID-19 over the last three days, according to The New York Times. They are all experiencing mild symptoms. Although they all attended a party retreat in Philadelphia over the weekend, it is unclear at this time if they caught the virus at the event.

Monday, March 14, 2022, 12:05 P.M. EDT

Obama Tests Positive for COVID-19

Barack Obama tweeted on Sunday that he tested positive for the coronavirus, but his only symptom is a scratchy throat. He and his wife Michelle (who tested negative) have been vaccinated and boosted. “It’s a reminder to get vaccinated if you haven’t already, even as cases go down,” said the 60-year-old former president.

Pfizer CEO Says Another Booster Will Be Needed

Albert Bourla, the CEO of Pfizer, said on Sunday that another COVID-19 booster shot would be necessary, although the FDA has yet to recommend a fourth dose, according to Politico. Bourla stressed the need to “to very diligently stay ahead of the virus” and said another shot could help with the vaccine’s waning protection over time.

Several European Countries See an Upswing in Cases

As COVID-19 infections continue to decline in the United States, analysis of data from the Johns Hopkins Coronavirus Resource Center by USA Today shows that cases rose over the past week in Germany, Italy, the Netherlands, Switzerland, and the United Kingdom. The United Kingdom, Netherlands, and Ireland have also seen an uptick in hospitalizations.

Ogbonnaya Omenka, PhD, an assistant professor and director of diversity at the Butler University College of Pharmacy and Health Science, told USA Today that America should be on the alert. “A wave in Europe, and other countries for that matter, might occur in the United States as well,” he said.

War in Ukraine May Spur New COVID-19 Surge

A feature in The New York Times on Saturday described how the war has forced Ukrainians into crowded and unsanitary conditions that are fertile ground for the coronavirus and other pathogens. The article also highlights how the country is also experiencing a rare outbreak of polio.

Omicron Is at Least 40 Percent More Lethal Than Flu, Research Finds

Bloomberg News reported on a yet-to-be published study out of Japan indicating that the omicron variant of COVID-19 is at least 40 percent deadlier than seasonal flu. Overall, researchers found that omicron’s case-fatality rate was around 0.13 percent, much lower than the 4.25 percent rate from earlier in the pandemic but higher than the 0.006 percent to 0.09 percent seen with the seasonal flu.

Kids With Asthma Not at More Risk of Coronavirus, Study Says

In a paper published Friday in the American Academy of Pediatrics journal Pediatrics, researchers discovered that of 706 children who tested positive for SARS-CoV-2 infection out of a total group pf 12,648 children, 350 (2.8 percent) had asthma and 356 (2.8 percent) did not have asthma. The study also noted that pediatric asthma patients were more likely to be tested for the virus compared with those without asthma (33 percent versus 20.9 percent).

China Faces Worst COVID-19 Outbreak in Two Years

China tallied 3,400 new cases on Sunday, double the previous day — an outbreak health authorities there are calling the worst in two years, according to The Guardian. Due to increasing clusters of omicron and delta variants, Shanghai has closed its schools and several northeastern cities have gone into lockdown.