FDA Asks Moderna, Pfizer to Add More Children to COVID-19 Vaccine Efficacy Studies

The U.S. Food and Drug Administration has asked Pfizer and Moderna to increase the number of school-age children in their ongoing clinical trials to determine if their COVID-19 vaccines are safe for children under 12 years old.

The two drug makers are currently testing their respective vaccines on children between five and 11 years old to assess their chances of developing rare heart inflammation conditions that have been detected in young people under 30 who received the vaccine. The conditions include myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the lining around the heart.

The request could delay formal approval of the two dose vaccines for children in that age group. Moderna, which enrolled nearly 7,000 children in its initial phase of the trial, says it is “actively discussing” the proposal with the FDA. Pfizer, which has enrolled up to 4,500 children between 6 months to 12 years old, says it expects to have results for the 5-11 age group in September, followed by results for ages 2-5 years old shortly after.

The Biden administration said Monday that it will maintain any existing travel restrictions to the United States due to the rise of the more contagious delta variant of COVID-19. The restrictions on dozens of nations across Europe and other parts of the globe, including China, were first imposed at the start of the pandemic in January 2020. The delta variant has been detected in more than 90 countries and comprises more than 80% of all new COVID-19 infections in the U.S.

The push for mandatory vaccinations among health care workers gained further momentum Monday when New York City announced a requirement for all of its municipal employees, including police officers and teachers, to either receive a COVID-19 vaccine or undergo weekly testing. The state of California also issued a mandatory vaccination order for all of its employees plus millions of public and private health care workers.

The two governments joined the U.S. Veterans Affairs department, which operates 1,700 medical centers and outpatient clinics for retired military personnel, in making vaccinations mandatory for most of its health care workers, becoming the first U.S. federal agency to impose such a demand.

In Australia, authorities in southern Victoria state said Tuesday that it will end a five-day hard lockdown on its 5 million residents imposed to battle a surge of new coronavirus infections due to the delta variant. Victoria state Premier Daniel Andrews said schools, bars and restaurants will be allowed to reopen, although households will not be permitted to welcome visitors.

Australia has been battling a surge of new COVID-19 cases since late June that has been traced to a Sydney airport limousine driver who tested positive for the delta variant after transporting international air crews. Health officials in New South Wales state, of which Sydney is the capital, reported a new single-day record of 172 new infections on Tuesday. Ten people have died during the latest surge.

Australia has been largely successful in containing the spread of COVID-19 through aggressive lockdown efforts, posting just 33,266 total confirmed cases and 922 deaths, according to the Johns Hopkins Coronavirus Resource Center. But it has proved vulnerable to fresh outbreaks due to a slow rollout of its vaccination campaign, with only 13% of its citizens fully vaccinated.

And Tokyo recorded 2,848 new COVID-19 infections Tuesday, a new single-day record for the host city of the pandemic-delayed Summer Olympics. The Japanese capital is under a fourth state of emergency that will remain in effect until August 22.

Source: Voice of America

2020 UN Country Annual Results Report March 2021

Foreword by Resident Coordinator

The United Nations welcomed the year 2020, as the beginning of the “Decade of Action” on the Sustainable Development Goals (SDGs).

The purpose is to deepen momentum for accelerating development, leaving poverty behind, taking action to stop the devastating effects of the climate crisis and supporting countries and communities living in conflict to transition to a peaceful world in line with the aspiration of the 2030 Agenda for Sustainable Development.

In 2020, the UN Country Team (UNCT) worked collaboratively with all stakeholders to journey with Malawi through elections and the fight against COVID-19. Malawi transitioned peacefully to a new Government overcoming a year of protests and political impasse since May 2019. The Economist declared Malawi Country of the Year due to her achievements. The COVID-19 pandemic hit Malawi in March 2020, seriously undermining the country’s prospects for development and exacerbating the already strained social and economic situation.

Malawi presented its first Voluntary National Review report for the implementation of the SDGs in June 2020. The report highlights progress after five years of SDGs implementation.

Malawi has made significant progress on 29 of the 169 targets (17%), moderate progress with performance gaps on 59 of the targets (35%), and shows insufficient progress on 81 of the targets (48%). The report raised the need to overcome present challenges to accelerate the implementation of the SDGs in the decade of action.

The annual report presents UN Malawi’s results under adverse circumstances, showing tangible progress on how lives were not just saved but bolstered; hunger was not just fought but diminished; jobs were not just safeguarded but more were created; the marginalised were not just counted but empowered, and Malawi’s democracy was not just strengthened but transitioned towards palpable maturity.

By July 2020, the UNCT had repurposed USD 50 million to strengthen institutions at the national and local level to prevent and address the socioeconomic impact and treat those infected by COVID-19. The UNCT mobilized additional resources to establish an oxygen plant with the capacity to generate one million litres of oxygen per day; provide cash transfers under the social protection schemes reaching 2.6 million Malawians in the rural areas and for the first time in the cities, and regularly reach over 14 million people with preventive messages across Malawi.

Sadly, one of the visible effects of the pandemic in Malawi was a spike in child pregnancies, unveiling the extent of sexual and genderbased violence (SGBV), which resulted in 40,000 reported child pregnancies and 13,000 child marriages. The UN used the Spotlight Initiative to expand and work with the national institutions, NGOs and other partners in nationally-led efforts to eliminate SGBV and child abuse. Over 40,000 cases of child rights violation were reported for action through UN-supported channels while 50 centres providing critical support to survivors of gender-based violence were supported. The UN is moving closer to our goal of ensuring that no woman or girl suffers any form of violence and is committed to the gender equality agenda that looks into women’s education, participation and economic empowerment as one of the most powerful accelerators of the SDG agenda.

UN Malawi is fully committed to the mandate of the General Assembly; to reposition the development system (A/RES/72/279) to a betterdefined collective identity as a trusted, reliable, cohesive, accountable and effective partner in the 2030 Agenda in 2020, and is working towards:

1) Greater impact; placing the ‘leave no one behind’ agenda at the centre of our interventions by systematically enhancing SDG data, focusing on work at the district level (the last mile) in a coordinated way, coupled with a dynamic context analysis and the systematic application of the rights-based approach.

2) Greater cohesion by leveraging on the capacities of all agencies, funds and programmes to address complex development issues: girls’ education, strengthening health systems, resilience building at the community level, eliminating violence against women and girls, social protection, integrating financing for SDGs, maternal wards connected to the COVID-19 centres and blended capital for agribusiness. Pool funding, from New York or locally-based through the Malawi SDG Acceleration Fund, ensured that over two years we increased from two joint programmes to the current eight involving most of the UNCT members.

3) Greater transparency guided the UN communications team to focus on SDGs, intensifying efforts during the COVID-19 period. A weekly situation report and numerous stories from the field helps in decision-making at the Humanitarian Country Team (HCT). The UN75 initiative provided a “whole of society” dialogue platform that was used for the national visioning 2063 exercise.

4) Visible shared results as we invest in a new way of working based on the co-leadership of Heads of Agencies and the Resident Coordinator.

5) Greater ownership of the Joint Annual Workplan per UNSDCF’ pillars by national authorities, thanks to the results-based dialogues.

With gratitude to the Government of Malawi for their leadership and the partnership of the international community present in Malawi, I invite you to read our report of activities in 2020 that presents some of the most salient results, successes and lessons learned.

Our success is counted in meaningful improvements in the lives of the people of Malawi. We will spare no effort to achieve this.

UN Resident Coordinator,

Ms. Maria Jose Torres

Source: United Nations

Malawi Adds More COVID-19 Vaccines in Attempt to Stem Surge

BLANTYRE, MALAWI – The Malawi government has announced it will start inoculating its citizens with several COVID-19 vaccines in an effort to protect more of its population amid growing coronavirus infections. Health Minister Khumbize Kandodo Chiponda says the extra vaccine is necessary to fill a gap.

Health Minister Khumbize Kandodo Chiponda says the COVID-19 vaccines Malawi has added include Pfizer, Johnson & Johnson, Moderna, Sputnik, Sinovac and Sinopharm.

Kandodo, who also is the co-chairperson of the Presidential Task Force on COVID-19, says the country is expected to receive a donation of 300,000 doses each of the Pfizer and Johnson and Johnson vaccines in early August.

“We have done this because we don’t want to put all our eggs in one basket, as has been the case,” said Kandodo. “That’s why we have opened up to include other vaccines, which can fill the gaps that would be created.”

She assured Malawians that the government has independently verified the safety and efficacy of the newly recommended vaccines.

Malawi stopped vaccinating its citizens in June when it ran out of the AstraZeneca vaccine.

Records show that about 400,000 people have been vaccinated — far short of the 11 million people needed to reach herd immunity.

In May, Malawi destroyed about 20,000 doses of AstraZeneca vaccine, which expired in April.

The incineration was largely because many Malawians were reluctant to be vaccinated due to concerns about the vaccine’s safety and efficacy.

Malawi is expected, however, to receive a fresh consignment of 192,000 doses of the AstraZeneca next week.

But Kandodo said the vaccine will be restricted to unvaccinated health workers and those who already have a single dose.

“We know there are a lot of people who are now willing to take the jab. But bear with us, other vaccines are coming,” said Kandodo. “And the importance of Johnson &Johnson’s is that it’s a single dose vaccine. So, those who have never taken any vaccines will take these Johnson & Johnson’s vaccines.”

Health rights campaigner Maziko Matemba is advising the government to make vaccine available through a standardized program and stop relying on donated vaccine.

“Vaccine has to be part of our routine program so that everyone who wants that vaccine needs to get it,” said Matemba. “Once you have the rights information and you are convinced that this is the vaccine that can save me, you should be able to get it, other than passing two to three weeks without vaccines at all.”

Kandodo said the problem Malawi is facing, though, is not about money to buy the vaccine but where to find it.

She said the Malawian government has just received about $30 million from the World Bank to help purchase COVID-19 vaccine.

Source: Voice of America

WHO, US Name Malawi a High Risk COVID-19 Country as Cases Spike

BLANTRYE, MALAWI – The World Health Organization and the U.S. Centers for Disease Control have designated Malawi a COVID-19 high risk country, and they are warning people against traveling to the southern African nation. The warning follows a surge in COVID-19 cases in a third wave of the pandemic.

Malawi is facing an unprecedented rise in COVID-19 cases in its third wave of the coronavirus pandemic, with an infection rate of 22%. That’s up from about 2 percent in May.

Statistics from the Ministry of Health released Friday show that for the previous 24 hours, Malawi confirmed 451 new COVID-19 cases and seven deaths.

In Its travel notice this week, the U.S. Centers for Disease Control and Prevention advised people to avoid traveling to Malawi.

It says if travel is necessary, individuals must make sure they are fully vaccinated before making the trip.

The CDC also says in the current situation in Malawi, even fully vaccinated travelers may be at risk of getting and spreading COVID-19 variants.

The World Health Organization has added Malawi to a list of African countries that expose people to a high risk of COVID-19 infection.

George Jobe is the executive director of the Health Equity Network. He says although the CDC’s travel notice was not expected, it hasn’t come as a surprise, considering the recent surge in COVID-19 cases.

“Therefore, declaration should be an eye-opener for Malawians to be very strict, observing the regulations that we have, and also for Malawi to enforce compliance of the regulations,” said Jobe. “That is what we need, especially that only 1 percent of Malawians have been vaccinated. Therefore, we are still prone to serious infections”

Malawi Health Minister Khumbize Kandodo Chiponda told a local radio station the announcement is not surprising and said it would affect the country’s tourism sector.

Economists say although the travel notice is logical, they nonetheless worry it will have a negative impact on the country, which depends greatly on international trade.

Betchani Tchereni is a professor of economics at the Malawi University of Business and Applied Sciences.

“If travel restrictions are being placed against us, we are going to face problems with having people to be attracted to come to Malawi for tourism purposes,” said Tchereni. “The second thing is, we want to attract the best investors from elsewhere, but if people cannot come here because they feel there is high risk of COVID-19, or indeed because they have been advised so, then you have problem. Remember, we are busy creating jobs in this country.”

To curb the pandemic, the Malawi government has reintroduced strict COVID-19 preventive measures. Restrictions include a ban on political rallies, no fans at stadiums for football games, no gatherings of more than 50 people, and a curfew from 10 p.m. to 6 a.m.

But Tchereni said Malawi has never been serious about enforcing the measures.

“Look, we have never been as very serious in Malawi. We have always said people should not gather, but have you been to markets? People are gathering in markets. People are gathering in schools, are everywhere people are doing so many things,” said Tchereni. “Yes, it is because of the nature of our economy, but you see what, we are going to lose lives and that is not good for the economy.”

The government says it has engaged the police and the military to help enforce the measures.

For example, police officers say that on Friday alone, they arrested about 40 people in a crackdown on those ignoring COVID-19 preventive measures.

Source: Voice of America

Malawi Rolls Out Second Jab Amid Vaccine Hesitancy

BLANTRYE, MALAWI – Malawi President Lazarus Chakwera led a rollout Friday of a push for a second dose of the COVID-19 vaccine, with a strong call to Malawians to go for vaccination to prevent a third wave of the coronavirus pandemic. The call came a day after health authorities in Malawi announced the presence of a more contagious Indian variant in the country, which has infected 14 people. Despite this, authorities bemoan the continued low vaccination rate.

During a televised event at the state residence in Lilongwe, Malawi President Lazarus Chakwera said he and Vice President Saulos Chilima decided to lead the campaign for a second dose of the AstraZeneca vaccine to prove its importance and safety.

He said this also was to dispel misconceptions and fears some Malawians have about the COVID-19 vaccination.

“The AstraZeneca vaccine we are using is a good vaccine whose aim is to protect us from COVID-19. That’s why my vice president and I were the first to have vaccinated in March, and now we want to become the first to have the second jab in public. Our aim is that you should be protected, there is no need to fear.”

The call came a day after health authorities in Malawi announced the presence of a more contagious Indian variant in the country that infected 14 people.

Despite the announcement of the Indian variant, the administration of the second jab has started in a low-key manner compared to the first dose.

For example, local media reported Friday that some vaccination centers were vaccinating just three people daily.

Health experts say this is largely because of lack of information on the importance of the second dose.

George Jobe is executive director for Health Equity Network.

“Our recommendation is that we need to package special jingles and messages tailored toward the second dosage,” said Jobe. “Those [messages] should fly in our media, encouraging those who got their first jab to get their second jab to complete. And we should also show the benefits of completing the dosage.”

Jobe also said there is a need to use community structures, like religious leaders and village chiefs, to encourage their subjects to get the second jab.

“What we noted recently, just a few weeks ago as we are getting close to a second jab, the negative information also resurfaced, threatening that people who got the vaccine may die,” said Jobe. “So, that probably has had an impact, that’s why we need more awareness raising and responding to such negative information.”

Malawi got a total 512,000 doses of AstraZeneca vaccines in March. The COVAX facility gave Malawi 360,000 doses, the African Union donated 102,000 doses and about 20,000 of those were destroyed last month after they expired. The Indian government donated 50,000 doses.

As of Thursday, only 355,000 doses had been used.

Another health rights campaigner, Maziko Matemba of the Health and Rights Education Program, says the problem is that Malawi has not created a lot of demand for these vaccines, especially for people in rural areas.

This, he says, has resulted in low uptake of the vaccine.

“We have only managed to vaccinate about one percent of the population because we have to vaccinate about 60 percent,” said Matemba. “So, for us, I think, the government and members of parliament could have made provisional budget to support the demand creation for the vaccine.”

Government authorities say they are now finalizing new awareness messages about the vaccine to help complement its ongoing campaign to encourage people to get the COVID-19 vaccine.

Source: Voice of America

South Asia Turns to China for COVID Vaccines after India Halts Exports

NEW DELHI – South Asian countries like Bangladesh and Sri Lanka are turning to China for vaccines for Covid 19 after India suspended vaccine exports due to critical shortages at home. Analysts say this will help Beijing increase its clout in the strategic Indian Ocean region where it has been building influence.

China has given 1.1 million doses of vaccines made by its Sinopharm Group company to Sri Lanka. Bangladesh received its first donation of half a million vaccines from China this month while Nepal has been promised an additional one million shots.

The shots from China are helping these countries restart inoculation drives that had stalled as supplies from India dried up. They come at a critical time — surging infections are raising fears that the torrid second wave which India is battling could impact neighboring countries.

“Make no mistake, India’s suspension of vaccine exports is a strategic opportunity for Beijing,” according to Michael Kugelman, the Deputy Director of the Asia Program and Senior Associate for South Asia at the Wilson Center. “China certainly sees its vaccine diplomacy as an image-building tactic at a time when Beijing has had a tough time with image management.”

As in many countries, there was some hesitancy in Sri Lanka and Bangladesh about Chinese-developed vaccines, but the emergency approval granted last month by the World Health Organization to Sinopharm’s has boosted its acceptance.

These countries had initially relied on India, which had also given AstraZeneca vaccines to several countries including Sri Lanka, Bangladesh and Nepal earlier this year. They had also placed commercial orders with the Serum Institute of India, the world’s largest vaccine producer, but many of those have not yet been fulfilled due to India’s surging need.

In a video conference with several South Asian countries last month, Beijing’s foreign minister, Wang Yi, offered to set up an emergency reserve of vaccines for the region.

Analysts say as China moves in to fill the gap left by India, Beijing’s “vaccine diplomacy” could give it leverage in the strategic Indian Ocean region, where it has been pushing its Belt and Road initiative that aims at building infrastructure projects across many countries.

“Given that this crisis will be with us for the foreseeable future, certainly there is going to be a sense of China becoming a very important player for many of these countries if India is not able to pick up some slack after a few months once things stabilize,” according to Harsh Pant, Director Studies and Head Strategic Studies program at the Observer Research Foundation in New Delhi.

In Sri Lanka, Beijing has already built several strategic infrastructure projects including port, roads and railways. It is now building a gleaming new port city off the coast of Colombo on reclaimed land.

The vaccines will add another dimension to its growing presence in the country, says political analyst, Asanga Abeyagoonasekera in Colombo. “China already has influence in Sri Lanka, but the vaccines represent another layer that would strengthen the Chinese influence. Chinese humanitarian assistance during the pandemic is always welcome but the question is whether it will deepen its strategic inroads,” according to Abeyagoonasekera.

China’s “vaccine diplomacy” may not be all about soft power, point out some analysts. The Chinese ambassador to Bangladesh recently said in Dhaka that any move to join the Quad would damage ties with China. The Quad, an informal strategic alliance which Beijing views as anti-China, comprises India, United States, Japan and Australia.

Bangladesh meanwhile has also urged Western countries to help as it runs out of AstraZeneca shots with which it rolled out its drive – more than a million citizens have not received the second shot.

Calling the vaccine situation a “crisis”, Foreign Minister A K Abdul Momen said recently that Bangladesh is “desperate” to get vaccines from countries like the U.S., Canada, Russia, China and Britain.

Analysts say it will be crucial for countries like the United States, which has promised to donate 80 million shots, to help those scrambling for vaccines in a region that is of strategic importance.

“The fact that Chinese are able to help countries at this point will go a long way in shaping those countries memories and remembrances of what happened at a very critical phase in global history,” according to Pant. “So, America would do well to respond to some of these issues. Of course, the question is how far and how fast they are willing to go, but that might really shape the way in which these small countries, small players in the Indo Pacific, South Asia, would look at their foreign policy.”

India, which had exported about 65 million doses before it shut down shipments, hopes to ramp up enough capacity to resume vaccine deliveries to other countries – but that may not happen till the end of the year.

“New Delhi has the opportunity to reassert itself further down the road. India is the world’s top manufacturer of vaccines, so it has an inherent comparative advantage over China,” points out Kugelman. China’s vaccine diplomacy, he says is aimed at promoting its image at a time when it has taken a hit both due to its expansionist policies and questions over how and where the COVID virus originated.

China has emerged as the world’s largest vaccine exporter as many countries across Asia, Africa and Latin America use shots from Beijing for their inoculation drives.

Source: Voice of America