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No need for a Covid booster shot now if people behave, says AIIMS Director Guleria

Vaccination coupled with Covid-appropriate behaviour is the way forward, even as the pandemic wanes and the disease becomes endemic, says Dr Randeep Guleria, director of the All India Institute of Medical Sciences, in a free-wheeling interview with Prerna Katiyar. Edited excerpts:

The Subject Expert Committee on Covid-19 has recommended vaccination for children. What is the feasibility given that the two vaccines likely to be approved for kids are Covaxin with a pretty low production level, and that Zydus has not started production yet?
The thing to remember in vaccinating children is that healthy children usually have mild disease. Therefore, if we roll it out, we must focus on children with comorbidities as they have a higher chance of dying and having severe illness with hospitalisation. That strategy of prioritisation is being developed just as we did in case of adults. The basic aim of vaccination, even in children, is to avoid severe illness and deaths. Once that is achieved, the next aim will be to decrease cases of mild illness by vaccinating as many people as we can. For children too, it will start with a high-risk group.

FDA has approved booster shots of Moderna and J&J. Are there plans to approve the same and do you think it is necessary?
Currently, I don’t think there is a need for a booster shot. If you look at data emerging from outside where there is still a surge in the number of cases, you find that if the people are vaccinated even with the initial dose, the area is not seeing a surge in hospitalisation or large breakthrough infection. This suggests that the vaccine is holding out and is still effective in preventing severe disease or deaths. So the priority should be to vaccinate as many people as we can with the first doses rather than giving additional doses to people, especially when we do not know how much it will benefit unless we find a high number of breakthrough cases in the elderly or a particular group which currently we are not. Also, this will deprive others as vaccine doses are limited. So we may need a booster dose in the future, but data suggest it is not required right now. Secondly, when we talk about booster dose, timing is important. It can’t be based on antibodies. So, should it be given after nine months or one year of the last dose? That data has to come out in a clear manner. Then should it be a repeat of the initial vaccine? What is the advantage of mix and match as some data show this can give better immune response? What combination should be there? Then what should be the priority group? Once all this is decided, only then can we move forward. Currently, we can’t say straight away that we need a booster dose.

As the vaccination rates rise, do we need to start looking at more metrics than just number of cases in order to make decisions on public health and reasonable precautions?
Yes definitely. We are now looking at different scenarios at some places where we are not seeing a large number of cases. So the number of cases can no longer be the defining factor. Defining factor could be the change in the number of cases or number of hospitalisations over a period of time like a week. Your baseline can’t be an absolute number but a trend. If one sees a trend of increasing cases, one can argue that the trend is on the upside which should alert people about the changing profile of the area. Then you should look at more aggressive testing surveillance and even genome sequencing to see if this is the same strain or a new strain is evolving.

How should people and the government look at Covid risks in a more and more vaccinated country?
There are two issues here: one, vaccination is a good protection but with immunity waning over time, it has its own limitations. Secondly, with new strains, the efficacy of the vaccine will come down because now the virus is multiplying in a vaccinated population. Previously the virus was not multiplying in a population that was vaccinated. So you were not seeing that much mutation. The number of mutations we have seen this year is much more than last year in terms of variants of concern. Also, no matter what the variant, Covid appropriate behaviour will still protect us. The chain of transmission can still be stopped this way. Vaccination is not a substitute for a Covid-appropriate behaviour but it is complement to it.

Do you think it is necessary to develop new versions of existing vaccines after taking inactivated viruses of new Covid variants?
Yes, this will happen and is happening. Lot of vaccine manufacturers are already in research. We could have next-gen vaccines which cover for the delta or beta variants. Also we could be looking at a bivalent or trivalent vaccine. Current vaccines have one strain but suppose we have a bivalent one that protects you both against delta and another variant-which is more effective. So in the near future, we may have next-generation vaccines which may cover for the new variants and may be bivalent or trivalent.

Latest serological survey shows 90% of people in Delhi have antibodies. So how would endemic be defined in case of Covid19 going forward?
Two things are important. A pandemic becomes endemic if you continue to have a few cases but it does not cause significant surge the way we saw in the first and second waves. Also, there is a good amount of immunity in the population so that the number of cases is limited. But the important thing is we will gradually reach that stage. Currently, it’s difficult to say we have reached that stage because right now we have immunity against a particular variant. This will wane with time. We are looking at antibodies present against a particular variant that may be circulating at that particular time. If you get a new variant, the efficacy of the antibodies will wane. So when we talk of good or herd immunity it is against a particular strain of the virus. If the virus changes and you get a new strain then the immunity against that strain will come down significantly and that is why we are more careful as we know the virus is still evolving – there is Delta plus variant, AY.4.2. So we need to see how it evolves but some degree of cross protection is always there. We have a good amount of immunity but a lot depends on how the virus evolves.

RDIF proposes Pfizer conduct joint trials with Sputnik Light as booster shot

The Russian Direct Investment Fund (RDIF) has proposed that US drugmaker

Pfizer

start joint trials with Sputnik Light as a booster COVID-19 vaccine shot, the RDIF said on Wednesday.

“Delta cases surge in US & Israel shows mRNA vaccines need a heterogeneous booster to strengthen & prolong immune response. #SputnikV pioneered mix&match approach, combo trials & showed 83.1% efficacy vs Delta. Today RDIF offers Pfizer to start trial with Sputnik Light as booster,” it said in a Tweet.

It further said that Sputnik V is the first in the world to offer combo trial to

AstraZeneca

in November 2020, co-sponsored mix&match trials with AstraZeneca, Moderna and Sinopharm.

“Sputnik V was the 1st in the world to offer combo trial to AstraZeneca in Nov 2020, co-sponsored mix&match trials with AstraZeneca, Moderna & Sinopharm. Since then heterogeneous boosting pioneered by Sputnik proved to be effective vs mutations,” it added further.

According to an official statement, the data collected by the health ministry confirms that Sputnik V remains protective against newly detected variants and retains one of the best safety and efficacy parameters.

The Russian Ministry of Health has also published data on Sputnik V’s efficacy against the Delta variant. The vaccine is 83.1 per cent effective and shows 6x reduction of infection risk. Sputnik V is also 94.4 per cent effective against hospitalizations with 18x reduction in hospitalisation risk,” the RDIF statement said.

Furthermore, real-world data obtained during mass vaccinations in Argentina, Bahrain, Hungary, Mexico, Russia, Serbia, the Philippines and UAE demonstrate lack of serious adverse events (such as CVTs or myocarditis). In several countries where multiple vaccines are used, the Russian vaccine has demonstrate done of the best safety and efficacy parameters.

At present, Sputnik V has been approved in 69 countries with total population exceeding 3.7 billion people – nearly half of the global population.

RDIF has concluded production partnerships with more than 20 companies in 14 countries, including the leading manufacturers in India, China, South Korea, Argentina, Mexico and other countries.

The RDIF statement also said that the two-dose Sputnik V vaccine, the single dose Sputnik Light vaccine is also demonstrating high safety and efficacy results in Argentina. Sputnik Light is the first component of Sputnik V (recombinant human adenovirus serotype number 26 (rAd26)).

In particular, data from the Ministry of Health of the province of Buenos Aires showed that Sputnik Light had helped to elicit antibodies in 94 per cent of those vaccinated and provided for a strong immune response.

J&J says second shot boosts protection for moderate-severe COVID-19 to 94%

Johnson & Johnson said Tuesday a second shot of its COVID-19 vaccine given about two months after the first increased its effectiveness to 94% in the United States against moderate to severe forms of the disease.

That compares to 70% protection with a single dose.

The data will help J&J make its case to U.S. regulators for a booster shot even as the company stresses the durability of its single-shot vaccine as a tool to ease the global pandemic.

President Joe Biden is pushing for booster shots in the face of surging hospitalizations caused by the Delta variant and J&J, the only drugmaker with a single-shot COVID-19 vaccine approved in the United States, has been under pressure to produce evidence on the effectiveness of an additional dose.

The company has now “generated evidence that a booster shot further increases protection against COVID-19,” Dr. Paul Stoffels, J&J’s chief scientific officer, said in a statement.

J&J said a booster given two months after the first dose increased antibody levels four to six-fold. When given six months after the first dose, antibody levels shot up twelve-fold, data released last month showed, suggesting a large improvement in protection with the longer interval between doses.

Side effects with two doses were comparable to those seen in studies with the single-dose vaccine. The data is yet to be peer reviewed but will be submitted for publication in the coming months.

To date, only Pfizer Inc/BioNTech SE have submitted sufficient data for U.S. regulators to evaluate whether boosters are warranted ahead of the Biden Administration’s Sept. 20 deadline for rolling out booster shots. A decision on that vaccine is expected this week.

On Friday, an FDA advisory committee voted to recommend emergency authorization of additional Pfizer shots for Americans 65 and older and those at high risk of severe illness, but voted to recommend against broader approval, saying they want to see more data.

J&J said it has submitted data to the FDA and plans to submit it to other regulators, the World Health Organization and other vaccine advisory groups worldwide to inform their decision-making.

The Phase III two-dose trial of up to 30,000 participants tested the effectiveness of a second dose given 56 days after the first in adults 18 and older.

While the study found that two doses of the J&J vaccine was 94% effective in the United States at preventing moderate to severe disease, there was only 1 case in the vaccine group and 14 in the placebo group, resulting in a wide confidence interval and raising questions about the certainty of the result.

The study had a short follow-up period of around 36 days, but found that a second dose was well tolerated, the company said.

The company also said on Tuesday that evidence from a separate real world study of nearly 400,000 people in the United States who got the J&J shot showed the vaccine was 79% effective at preventing COVID-19 infections and 81% effective at preventing hospitalizations compared with 1.52 million people of similar ages, genders and health issues who were unvaccinated.

J&J said there was no evidence of reduced effectiveness over the study’s duration from March to late July – a period that included the impact of the Delta variant.

Vaccine effectiveness in the real world study varied by age. For those under age 60, the vaccine was 86% effective at preventing hospitalization versus 78% for those 60 and older.

Moderna plans mix of COVID-19 vaccine doses with new Lonza deal

Moderna is gearing up to halve the dose of its COVID-19 vaccine, the U.S. drugmaker said on Wednesday, so that it can also be used to combat variants and inoculate children.

It has agreed a deal with Swiss-based drugmaker Lonza which said a new drug substance production line in Geleen, Netherlands, will have capacity to make ingredients for up to 300 million doses annually at 50 micrograms per dose.

“We’re assuming that as of 2022, we are going to have a mix of dose levels on the market,” a spokeswoman for Moderna said, following the announcement of Lonza’s new production.

Moderna, which has been studying lower-dose versions to help stretch supplies of its vaccine, has been delivering an approved 100-microgram dose to date.

The drugmaker has said early booster shot data for a 50-microgram version showed it helped protect against emerging virus variants. Lower-doses may also be given to children who may not require a full one.

Combined with a previous deal with Spain’s Rovi, Moderna’s pact with Lonza brings 50-microgram production in Europe to up to 600 million doses annually, with the capacity due to come on line this year.

Pfizer’s and BioNTech‘s mRNA shot has been approved for 12-15 year olds in Europe and the United States, and Moderna is aiming for approval for teens as data showed its shot has been found safe and effective.

Moderna aims to deliver up to 3 billion doses in 2022, up from 800 million to 1 billion doses this year, but has not specified the dosing mix.

In addition to the planned Dutch production, Lonza has three production lines in Visp, Switzerland, where it is ramping up annual capacity to 300 million doses at 100 micrograms per dose. In April, it announced plans to double Visp production by next year.

The Swiss drugmaker also produces ingredients for Moderna in the United States. Sweden’s Recipharm, Samsung Biologics as well as ThermoFisher, which inked a deal with Moderna this week, also have roles in making the shot.

US to recommend COVID vaccine boosters at 8 months: Sources

U.S. health experts are expected to recommend COVID-19 vaccine boosters for all Americans, regardless of age, eight months after they received their second dose of the shot, to ensure lasting protection against the coronavirus as the delta variant spreads across the country.

Federal health officials have been actively looking at whether extra shots for the vaccinated would be needed as early as this fall, reviewing case numbers in the U.S. as well as the situation in other countries such as Israel, where preliminary studies suggest the vaccine’s protection against serious illness dropped among those vaccinated in January.

An announcement on the U.S. booster recommendation was expected as soon as this week, according to two people familiar with the matter who spoke to The Associated Press on the condition of anonymity to discuss internal deliberations.

Doses would only begin to be administered widely once the Food and Drug Administration formally approves the vaccines. That action is expected for the Pfizer shot in the coming weeks.

Last week, U.S. health officials recommended boosters for some with weakened immune systems, citing their higher risk of catching the virus and evidence that the vaccines’ effectiveness waned over time.

The director of the National Institutes of Health, Dr. Francis Collins, said Sunday the U.S. could decide in the next couple weeks whether to offer coronavirus booster shots to Americans this fall.

Among the first to receive them could be health care workers, nursing home residents and other older Americans, who were some of the first Americans to be vaccinated once the shots received emergency use authorization last December.

Since then, more than 198 million Americans have received at least one dose of a COVID-19 vaccine according to the Centers for Disease Control and Prevention, with more than 168 million fully vaccinated. Still, the country is experiencing a fourth surge of virus cases due to the more transmissible delta variant, which is spreading aggressively through unvaccinated communities but is also responsible for an increasing number of so-called “breakthrough infections” of fully vaccinated people.

Israel, which exclusively administered the Pfizer shot, has been offering a coronavirus booster to people over 60 who were already vaccinated more than five months ago in an effort to control its own surge in cases from the delta variant.

For months, officials had said data still indicated that people remain highly protected from COVID-19, including the delta variant, after receiving the two-dose Pfizer or Moderna regimen or the one-shot Johnson & Johnson vaccine. But U.S. health officials made clear Sunday they are preparing for the possibility that the time for boosters may come sooner than later.

“There is a concern that the vaccine may start to wane in its effectiveness,” Collins said. “And delta is a nasty one for us to try to deal with. The combination of those two means we may need boosters, maybe beginning first with health care providers, as well as people in nursing homes, and then gradually moving forward” with others, such as older Americans who were among the first to get vaccinations.

He said because the delta variant only started hitting the U.S. hard in July, the “next couple of weeks” of case data will help the U.S. make a decision.

Officials were continuing to collect information as well about the J&J vaccine, which was only approved in the U.S. in late February, to determine when to recommend boosters, one of the officials said.

The White House has said that even though the U.S. has begun sharing more than 110 million vaccine doses with the world, the nation has enough domestic supply to deliver boosters to Americans should they be recommended by health officials.

Global health officials, including the World Health Organization, have called on wealthier and more-vaccinated countries to hold off on booster shots to ensure the supply of first doses for people in the developing world.

WHO chief Tedros Adhanom Ghebreyesus urges halt to booster shots for rest of the year

The head of the World Health Organization is calling on rich countries with large supplies of coronavirus vaccines to refrain from offering booster shots through the end of the year, expanding an earlier request that has largely fallen on deaf ears.

WHO Director-General Tedros Adhanom Ghebreyesus also said Wednesday that he was “appalled” at comments by a leading association of pharmaceutical manufacturers a day earlier who said vaccine supplies are high enough to allow for both booster shots and vaccinations in countries in dire need of jabs but facing shortages.

“I will not stay silent when companies and countries that control the global supply of vaccines think the world’s poor should be satisfied with leftovers,” he told a news conference in Geneva.

Tedros had previously called for a “moratorium” on booster shots through the end of September. But wealthy nations countries – including Israel, Britain, Denmark, France, Germany, Spain and the United States – have begun or are considering plans to offer third shots of two-dose vaccines to their vulnerable people such as the elderly or those with compromised immune systems.

The WHO chief said he received a message of “clear support” from health ministers at a meeting of the influential Group of 20 countries this month for a commitment to help hit a WHO target that all countries vaccinate at least 40% of their people by year’s end.

“A month ago, I called for a global moratorium on booster doses, at least until the end of September to prioritize vaccinating the most at risk people around the world who are yet to receive their first dose,” Tedros said. “There has been little change in the global situation since then.”

“So today, I’m calling for an extension of the moratorium until at least the end of the year to enable every country to vaccinate at least 40% of its population,” he said.

WHO says 5.5 billion coronavirus vaccines have been administered so far, but 80% of those have been to upper- and middle-income countries. Rich countries have also offered to donate 1 billion vaccine doses to other countries, but under 15% of those doses have “materialized,” Tedros said, noting that manufacturers have pledged to prioritize a U.N.-backed program to get vaccines to the neediest people in the world.

“We don’t want any more promises. We just want the vaccines,” the WHO chief said.