BioNTech says vaccine repeats beat devising new one for now

By Ludwig Burger

FRANKFURT (Reuters) -BioNTech said that repeat shots of its COVID-19 vaccine, of which more than a billion doses have now been supplied worldwide, was a better strategy than tailoring the product it developed with Pfizer to new variants.

The German biotech firm said that offering a third dose of its established two-shot vaccine remained the best response to concerns over waning immune protection in the face of the highly contagious Delta variant, as worse strains may emerge.

BioNTech said the more than one billion supply tally as per July 21 was up from 700 million-plus doses it announced in June.

This compares with AstraZeneca saying last month that it and manufacturing partner Serum Institute of India had supplied a billion doses of its vaccine globally.

Based on delivery contracts signed for more than 2.2 billion doses so far, BioNTech said in a statement detailing its second quarter earnings that it expects to accrue 15.9 billion euros ($18.7 billion) in revenue from the vaccine this year, up from a May forecast of 12.4 billion euros.

That includes sales, milestone payments and a share of gross profit in its partners’ territories, BioNTech added.

Pfizer late last month raised its forecast for its share of 2021 vaccine sales to $33.5 billion and said at the time it believes people will need a third dose of the shot.

Pfizer and BioNTech’s decision in early July to seek authorization for a third dose drew criticism from U.S. health regulators, who said there was not yet enough data to show booster shots are needed.

U.S. health agencies have since discussed additional doses for people with compromised immune systems, while Germany and France said they would roll out a third dose for the most vulnerable from September.

That jars with a call by the World Health Organization to use doses instead to jump-start vaccination campaigns in poorer nations which have so far been left behind.

BioNTech Chief Executive Ugur Sahin said that although work was ongoing to adjust the vaccine to variants it was not clear whether yet another version of the pathogen would supplant the now prevalent Delta variant.

“Making a decision at the moment might turn out to be wrong in three or six months if another variant is dominating,” Sahin said during an analyst call.

Chief Medical Officer Oezlem Tuereci said lab experiments had shown that a third shot of the established product generated neutralizing antibodies against a range of strains and that the antibody boost was above the one following a second dose.

Still, the company reiterated plans to start testing a vaccine adjusted to the Delta variant on humans this month, part of a “comprehensive strategy to address variants.”

($1 = 0.8509 euros)

(Reporting by Ludwig BurgerEditing by Chizu Nomiyama and Alexander Smith)

Vietnam to mix doses of Pfizer, AstraZeneca COVID-19 vaccines

HANOI(Reuters) – Vietnam will offer the coronavirus vaccine jointly developed by Pfizer and BioNTech as a second dose option for people first inoculated with the AstraZeneca vaccine, the government said on Tuesday.

Vietnam’s mass inoculation campaign is in its early stages, with fewer than 300,000 people fully vaccinated so far. It has so far used AstraZeneca’s viral vector vaccine and last week took delivery of 97,000 doses of the Pfizer-BioNTech mRNA shot.

“Pfizer vaccines will be prioritized for people who were given first shot of AstraZeneca 8-12 weeks before,” the government said in a statement.

Several countries, including Canada, Spain and South Korea, have already approved such dose-mixing mainly due to concerns about rare and potentially fatal blood clots linked to the AstraZeneca vaccine.

A Spanish study found the Pfizer-AstraZeneca combination was highly safe and effective, according to preliminary results.

But the World Health Organization’s chief scientist advised on Monday against mixing and matching COVID-19 vaccines, calling it a “dangerous trend” since there was little data available about the health impact.

The Vietnamese government in a separate statement said its health ministry was in talks with India to secure 15 million doses of COVID-19 vaccine Covaxin.

The country has so far received around 8 million doses of vaccines from multiple sources, including international COVAX scheme, donations and its own purchases.

Vietnam has been trying to expedite its vaccination campaign as the pace of infections grow, having hit daily records eight times this month. It reported 2,031 new infections on Tuesday, most of those in the epicenter Ho Chi Minh City.

Prior to May 2021, it had recorded less than 3,000 coronavirus cases in total. Its caseload is now 34,500, with 130 deaths.

Vietnam said on Tuesday it would soon receive 1.5 million doses of the AstraZeneca vaccine donated by Australia and an additional batch of one million doses of the vaccine from Japan this week.

(Editing by Ed Davies and Martin Petty)

Pandemic tied to spike in diabetes in children; type of immune response lasts months after Pfizer/BioNTech vaccine

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Pandemic tied to sharp rise in type 2 diabetes in kids

Hospitalization rates for children with newly diagnosed type 2 diabetes more than doubled during the pandemic, two hospitals reported at the American Diabetes Association Scientific Sessions, held virtually this year. At Our Lady of the Lake Children’s Hospital in Baton Rouge, Louisiana, children with newly diagnosed type 2 diabetes accounted for 0.62% of inpatients from March through December 2020, up from 0.27% the year before. Those numbers are low, “but just the fact that this rate has more than doubled over the past year is … significant,” said Dr. Daniel Hsia of Pennington Biomedical Research Center in Baton Rouge. Children hospitalized in 2020 had more severe diabetes, with higher blood sugar and more dehydration, than children admitted in the prior year, he said. At Children’s National Hospital in Washington, DC, cases of new-onset type 2 diabetes in children increased 233% from 2019 to 2020 – and the children were sicker than in previous years, a separate team reported. Most of these children at both hospitals had not previously had COVID-19. Social distancing measures may have kept children from having regular physical activity and contributed to weight gain, and also kept parents from taking them for routine medical care, all of which may have contributed to more severe illness, researchers speculated. “Our study reinforces the importance of maintaining a healthy lifestyle for children even under such difficult circumstances” Hsia said in a statement.

Immune cell “factories” work longer after mRNA vaccines

The tiny “factories” in lymph nodes that churn out antibody-producing B cells to fight infections, called germinal centers, were still functioning to hold COVID-19 at bay for months after people received the mRNA vaccine from BioNTech and Pfizer, according to a new study. After most vaccines, germinal centers last only a few weeks. “Germinal centers are the key to a persistent, protective immune response,” said Ali Ellebedy of Washington University School of Medicine in St. Louis, who coauthored a report on Monday in Nature. “Germinal centers are where our immune memories are formed. And the longer we have a germinal center, the stronger and more durable our immunity will be because there’s a fierce selection process happening there, and only the best immune cells survive.” Researchers studied cells from germinal centers in armpit lymph nodes of 14 recipients of the Pfizer/BioNTech vaccine. Three weeks after the first dose, all 14 had germinal centers that were still generating B cells. B-cell production “expanded greatly” after the second shot and stayed high, they reported. Eight of 10 people biopsied 15 weeks after the first dose, still had functioning germinal centers. “We’re still monitoring the germinal centers, and … in some people, they’re still ongoing,” Ellebedy said. “This is truly remarkable.” The same effect is likely also true for Moderna’s mRNA vaccine, the researchers believe. Ultimately, immune cells called T cells are what sustains the germinal centers’ work after they disappear. The researchers plan next to investigate the magnitude and durability of T cell responses after mRNA COVID-19 vaccines.

Following AstraZeneca with Pfizer shot boosts antibody response

Giving a dose of the Pfizer/BioNTech COVID-19 vaccine four weeks after an AstraZeneca shot produces better immune responses than a second dose of AstraZeneca’s, Oxford University researchers said on Monday. In a study of 830 older adults, mixed two-dose schedules of AstraZeneca and Pfizer vaccines produced higher concentrations of antibodies against the coronavirus that a full schedule of the AstraZeneca shot. The most effective approach – two doses of Pfizer/BioNTech mRNA vaccine – produced levels of antibodies about 10 times higher than two doses of the AstraZeneca vaccine, the researchers reported on Friday in a Lancet preprint. However, the AstraZeneca shot followed by a Pfizer jab induced antibody levels about as high as two Pfizer/BioNTech doses. Giving the Pfizer shot first, followed by AstraZeneca’s, was not as successful. That combination yielded antibody levels higher than two AstraZeneca shots but lower than two doses of the Pfizer vaccine. There were no new safety issues uncovered in the study. Matthew Snape, the Oxford professor behind the trial, said the findings could be used to give flexibility to vaccine rollouts but were not significant enough to recommend a broad shift away from clinically approved schedules.

COVID-19, not Pfizer’s vaccine, tied to Bell’s palsy

The Pfizer/BioNTech vaccine has not been linked with a higher risk for the facial nerve paralysis known as Bell’s palsy, but COVID-19 itself does increase the risk, suggest two separate studies published on Thursday in JAMA Otolaryngology-Head and Neck Surgery. One study involved 110 people in Israel who received the Pfizer vaccine, including 37 in whom the characteristic facial droop developed on average nine days after the first dose or 14 days after the second. After accounting for underlying risk factors for Bell’s palsy, the researchers concluded the vaccine itself did not increase the risk. Furthermore, they found, rates of Bell’s palsy had not gone up during the vaccine rollout. In the second study, researchers compared Bell’s palsy rates among roughly 348,000 patients with COVID-19 and roughly 63,500 people who had been vaccinated against the coronavirus. The Bell’s palsy risk was nearly seven times higher in those with COVID-19, they found. “Our data suggest that rates of facial nerve palsy are higher in patients who are positive for COVID-19, and this incidence exceeds the reported incidence of Bell’s Palsy with the COVID-19 vaccine,” said Dr. Akina Tamaki of University Hospitals Cleveland Medical Center, who coauthored that study. “Taken together, it supports that the vaccine is safe from a facial nerve paralysis standpoint.”

(Reporting by Nancy Lapid, Megan Brooks, Marilynn Larkin and Alistair Smout; Editing by Bill Berkrot)

‘Likely link’ between rare heart inflammation and Pfizer, Moderna vaccines -CDC advisers

By Michael Erman and Manojna Maddipatla

(Reuters) -Rare cases of heart inflammation in adolescents and young adults is likely linked to vaccination with the Pfizer/BioNTech and Moderna COVID-19 shots, a group of doctors advising the U.S. Centers for Disease Control and Prevention (CDC) said in a presentation released on Wednesday.

The COVID-19 Vaccine Safety Technical (VaST) Work Group said in their report that the risk of myocarditis or pericarditis following vaccination with the mRNA-based shots in adolescents and young adults is notably higher after the second dose and in males.

The CDC said in another report that the patients with heart inflammation following vaccination generally recover from the symptoms and do well.

The Advisory Committee on Immunization Practices (ACIP) is meeting on Wednesday to assess the possibility of a link between the heart condition and the mRNA vaccines. VaST is a sub-group of ACIP.

The CDC has been investigating cases of heart inflammation mainly in young men for several months. The Israeli health ministry earlier this month said it saw a possible link between such cases and Pfizer’s COVID-19 vaccine.

The CDC earlier this month said it was still evaluating the risk from the condition and did not confirm a causal relationship between the vaccines and the heart issue.

The agency, however, said a higher-than-expected number of young men have experienced heart inflammation after their second dose of the mRNA COVID-19 shots, with more than half the cases reported in people between the ages of 12 and 24.

Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said in a presentation that data from one of the agency’s safety monitoring systems – Vaccine Safety Datalink (VSD) – suggests a rate of 12.6 cases per million in the three weeks after the second shot in 12- to 39-year-olds.

ACIP will discuss the benefits of the mRNA vaccines versus the potential risk to adolescents and young adults from the heart condition, according to the agency’s agenda.

Although health officials in Israel have determined that there is likely a link between vaccination and the heart inflammation, concerns about the more infectious Delta coronavirus variant have prompted the country to urge 12-to 15-year old’s get vaccinated.

Pfizer, whose vaccine has been authorized for use in Americans as young as 12, previously said it had not observed a higher rate of heart inflammation than would normally be expected in the general population.

Moderna had said it could not identify a causal association with the heart inflammation cases and its vaccine.

Over 138 million Americans have so far been fully vaccinated with one of the two mRNA vaccines, according to CDC data as of Monday.

(Reporting by Michael Erman in New Jersey and Manojna Maddipatla in Bengaluru; Editing by Bill Berkrot)

Pfizer to test COVID-19 vaccine in larger group of children below 12

By Michael Erman and Ankur Banerjee

(Reuters) – Pfizer Inc said on Tuesday it will begin testing its COVID-19 vaccine in a larger group of children under age 12 after selecting a lower dose of the shot in an earlier stage of the trial.

The study will enroll up to 4,500 children at more than 90 clinical sites in the United States, Finland, Poland and Spain, the company said.

Based on safety, tolerability and the immune response generated by 144 children in a phase I study of the two-dose shot, Pfizer said it will test a dose of 10 micrograms in children between 5 and 11 years of age, and 3 micrograms for the age group of 6 months to 5.

A Pfizer spokesperson said the company expects data from 5- to 11-year-olds in September and would likely ask regulators for emergency use authorization later that month. Data for children 2 to 5 years old could arrive soon after that, he said.

Pfizer expects to have data from the 6-month to 2-year-old age group sometime in October or November.

The vaccine – made by Pfizer and German partner BioNTech SA – has been authorized for use in children as young as 12 in Europe, the United States and Canada. They receive the same dose as adults: 30 micrograms.

Nearly 7 million teens have received at least one dose of the vaccine in the United States, according to the U.S. Centers for Disease Control and Prevention.

Inoculating children and young people is considered a critical step toward reaching “herd immunity” and taming the COVID-19 pandemic.

Still, scientists in the United States and elsewhere are studying the possibility of a link between heart inflammation and mRNA vaccines, particularly in young men. Both Pfizer and Moderna Inc’s vaccines are mRNA shots.

Israel’s Health Ministry said last week it had found the small number of myocarditis cases observed mainly in young men who received the Pfizer vaccine there were probably linked to their vaccination. The cases were generally mild and did not last long.

Pfizer has said it is aware of the Israeli observations of myocarditis and that no causal link to its vaccine has been established.

(Reporting by Ankur Banerjee in Bengaluru and Michael Erman in New York; Editing by Arun Koyyur, Will Dunham and Mark Heinrich)

India, big vaccine exporter, now vaccine exporter as COVID-19 cases soar

By Alasdair Pal and Krishna N. Das

NEW DELHI (Reuters) -India on Tuesday said it will fast-track emergency approvals for COVID-19 vaccines authorized by Western countries and Japan, paving the way for possible imports of Pfizer, Johnson & Johnson, and Moderna shots.

The move, which will exempt companies from carrying out local safety trials for their vaccines, follows the world’s biggest surge in cases in the country this month.

Since April 2, India has reported the highest daily tallies of infections. It reported 161,736 cases on Tuesday, taking the total to 13.7 million, while deaths rose by 879 to 171,058.

On Tuesday, India’s richest state Maharashtra, which accounts for about a quarter of the country’s cases, said it would impose stringent restrictions from Wednesday to try to contain the spread.

India has the biggest global vaccine manufacturing capacity and had exported tens of millions of doses before its own demand skyrocketed and led to a shortage in some states.

Dozens of poor countries have relied on Indian exports to run their inoculation drives.

The health ministry said vaccines authorized by the World Health Organization or authorities in the United States, Europe, Britain and Japan could be granted emergency use approval in India.

“If any of these regulators have approved a vaccine, the vaccine is now ready to be brought into the country for use, manufacture and fill-and-finish,” Vinod Kumar Paul, a senior government health official, told a news conference.

“We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others … to be ready to come to India as early as possible.”

Pfizer said it would work towards bringing its vaccine to India after withdrawing its application in February.

U.S. federal health agencies on Tuesday recommended pausing use of the J&J shot after six women under age 50 developed rare blood clots after receiving it.

India has administered more than 108 million vaccine doses, sold more than 54.6 million vaccine doses abroad and gifted more than 10 million to partner countries.

It is currently using the AstraZeneca shot and a homegrown vaccine for its own immunization drive, and this week approved Russia’s Sputnik V shot for emergency use.

RALLIES, RELIGIOUS GATHERINGS

The jump in India’s infections, for which Health Minister Harsh Vardhan acknowledged widespread failure to heed curbs on movement and social interaction, has prompted calls for the government to cancel huge public events.

Still, hundreds of thousands of devout Hindus are set to bathe in the Ganges river on Wednesday, the third key day of the weeks-long Kumbh Mela – or pitcher festival.

Nearly a million bathed in the Ganges on Monday in the belief that its waters would wash away their sins. More than 100 tested positive for COVID-19 in random testing of around 18,000 attendees, media said.

Similar concerns of a spike in cases were sparked by mass election rallies by Prime Minister Narendra Modi’s party and opposition groups during polls in four states and one federally run region.

At one rally in the eastern state of West Bengal, a key political prize, Home Minister Amit Shah posted Twitter pictures of meetings with crowds of supporters while unmasked.

DEADLY SPREAD

The second wave of infections, which began in India’s major cities, is increasingly spreading into the hinterland, where healthcare facilities are often rudimentary.

In Raipur, the capital of Chhattisgarh state known for its large tribal population, the main government hospital’s morgue was struggling to keep up, said joint director Dr Vineet Jain.

“All oxygenated and ICU beds are full in our set-up,” he told Reuters.

“Around 50 dead bodies are laying, we have a shortage of space. Some private hospitals do not have space to keep the dead bodies so they also send the bodies to us.”

India is currently reporting around double the daily cases of the United States and Brazil, the two other worst affected countries, though its daily death toll is lower.

India’s total infections rank after only the United States, having overtaken Brazil on Monday.

(Reporting by Krishna N. Das and Alasdair Pal in New Delhi and Jatindra Dash in Bhubaneswar; Editing by Nick Macfie, Ana Nicolaci da Costa and John Stonestreet)

Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine in adolescents

By Michael Erman and Mrinalika Roy

(Reuters) – Pfizer Inc and its German partner BioNTech SE on Friday asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15.

The vaccine is currently authorized for emergency use in the United States for people aged 16 and up. The companies said on Friday that they requested an expansion of the authorization from the U.S. Food and Drug Administration to include the younger age group.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year old’s in a clinical trial.

It is unclear how long the regulator will take to review the data from the trial, although U.S. Centers for Disease Control director Rochelle Walensky told ABC news on Thursday that she expects the vaccine to be authorized for 12 to 15 year olds by mid-May.

It is also unclear whether the regulator will require a meeting of the independent advisory board that recommended the original authorization in order for the companies to receive the nod in the younger age group.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year old’s, and data from Moderna’s trial could come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

Inoculating children and young people is considered a critical step toward reaching herd immunity and taming the pandemic, according to many experts.

Pfizer and BioNtech said they plan to ask other regulatory authorities globally to allow the use of their vaccine in 12- to 15-year old’s in the coming days.

Pfizer, Moderna COVID-19 vaccines highly effective after first shot in real-world use, -U.S. study

By Ankur Banerjee and Vishwadha Chander

(Reuters) – COVID-19 vaccines developed by Pfizer Inc with BioNTech SE and Moderna Inc reduced the risk of infection by 80% two weeks or more after the first of two shots, according to data from a real-world U.S. study released on Monday.

The risk of infection fell 90% by two weeks after the second shot, the study of just under 4,000 vaccinated U.S. healthcare personnel and first responders found.

The study by the U.S. Centers for Disease Control and Prevention (CDC) evaluated the vaccines’ ability to protect against infection, including infections that did not cause symptoms. Previous clinical trials by the companies evaluated their vaccine’s efficacy in preventing illness from COVID-19.

The findings from of the real-world use of these messenger RNA (mRNA) vaccines confirm the efficacy demonstrated in the large controlled clinical trials conducted before they received emergency use authorizations from the U.S. Food and Drug Administration.

The study looked at the effectiveness of the mRNA vaccines among 3,950 participants in six states over a 13-week period from Dec. 14, 2020 to March 13, 2021.

“The authorized mRNA COVID-19 vaccines provided early, substantial real-world protection against infection for our nation’s healthcare personnel, first responders, and other frontline essential workers,” CDC Director Rochelle Walensky said in a statement.

The new mRNA technology is a synthetic form of a natural chemical messenger being used to instruct cells to make proteins that mirror part of the novel coronavirus. That teaches the immune system to recognize and attack the actual virus.

The CDC study comes weeks after real-world data from Israel suggested that the Pfizer/BioNTech vaccine was 94% effective in preventing asymptomatic infections.

Some countries, including Britain and Canada, are allowing extended gaps between doses that differ from how the vaccines were tested in clinical trials in order to alleviate supply constraints. In the trials, there was a three-week gap between Pfizer shots and four weeks for the Moderna vaccine.

In Britain, authorities said in January that data supported its decision to move to 12 weeks between the first and second Pfizer/BioNtech shots. Pfizer and its German partner have warned that they had no evidence to prove that.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Peter Henderson and Bill Berkrot)

EU export restrictions on COVID shots would be ‘lose-lose’ situation: Pfizer executive

By John Miller

ZURICH (Reuters) – European Union export restrictions on COVID-19 vaccines would result in a ‘lose-lose’ situation for everyone, including EU members, a Pfizer executive said, a day after the bloc tightened oversight of shot deliveries beyond its borders.

The EU’s action would give it greater scope to block shipments to countries with higher inoculation rates such as Britain, or which are not sharing doses that they produce.

The specter of export restrictions has many concerned, given the global nature of vaccine production, in which shots have hundreds of ingredients sourced in dozens of countries. New roadblocks for shots or raw materials could disrupt pandemic-fighting efforts as the world struggles to contain a third wave of infections, companies fear.

“We have observed these recent developments with concern,” Sabine Bruckner, Swiss country manager for Pfizer, said at a Swiss government press conference on Thursday.

“Our executive leadership has been in direct contact with the European Union. Our position has been laid out, we are very critical, we can’t support it at all,” she added.

“Should it really come to export restrictions, that would be a ‘lose-lose’ situation for everyone, also for the members of the European Union.”

The new rules set out by the European Commission, which oversees EU trade policy, expand existing measures aimed at ensuring planned exports by drugmakers do not threaten the bloc’s supply.

They add 17 previously exempt countries including Israel, Norway and Switzerland to the list of countries for which exports of EU-produced vaccines require licenses. Switzerland, for instance, gets its Pfizer COVID-19 shots from a plant in Belgium.

Pfizer’s Bruckner made the comments after a Swiss vaccine summit in which Health Minister Alain Berset predicted his country would receive 10.5 million vaccines from suppliers including Pfizer and Moderna by July, enough to vaccinate everybody in Switzerland who wants a shot, he said.

(Reporting by John Miller in Zurich and Philip Blenkinsop in Brussels; Editing by Elaine Hardcastle)

Pfizer, BioNTech launch COVID-19 vaccine trial in kids under 12

By Michael Erman

(Reuters) – Pfizer Inc and German partner BioNTech SE began testing their COVID-19 vaccine in children under 12, with hopes of expanding vaccination to that age range by early 2022, the U.S. drugmaker said on Thursday.

The first volunteers in the early-stage trial were given their first injections on Wednesday, Pfizer spokesperson Sharon Castillo said.

The Pfizer/BioNTech vaccine was authorized by U.S. regulators in late December for people age 16 and older. Nearly 66 million doses of the vaccine had been administered in the United States as of Wednesday morning, according to data from the U.S. Centers for Disease Control and Prevention.

The pediatric trial, which will include children as young as 6 months, follows a similar one launched by Moderna Inc last week.

Only the Pfizer/BioNTech vaccine is being used in 16- and 17-year-olds in the United States. Moderna’s shot was cleared for those age 18 and older, and no COVID-19 vaccine has been authorized in younger kids yet.

Pfizer and BioNTech plan to initially test the safety of their two-shot vaccine at three different dosages – 10, 20 and 30 micrograms – in a 144-participant Phase I/II trial.

They plan to later expand to a 4,500-participant late-stage trial in which they will test the safety, tolerability and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects.

Castillo said the companies hope to have data from the trial in the second half of 2021.

Meanwhile, Pfizer has been testing the vaccine in children from age 12 to 15. The company expects to have data from that trial in the coming weeks, Castillo said.

(Reporting by Michael Erman; Additional reporting by Julie Steenhuysen in Chicago; Editing by Bill Berkrot)