FDA taps Sinovac for seniors


The Food and Drug Administration (FDA) on Wednesday approved use of Sinovac’s COVID-19 vaccine for people 60 years and older, overturning its earlier advice against using it for seniors because of the lack of data for that age group.

The Food and Drug Administration (FDA) on Wednesday approved use of Sinovac’s COVID-19 vaccine for people 60 years and older, overturning its earlier advice against using it for seniors because of the lack of data for that age group.

The FDA approval comes amid a shortage of vaccines from AstraZeneca, which were approved for use for seniors.

The Philippine Vaccine Expert Panel (VEP) had earlier recommended that the Chinese-made Sinovac vaccine be used on the elderly, saying the benefits of using it would outweigh the risks.

Dr. Nina Gloriani, the head of the VEP, said clinical trials of the Sinovac vaccine in Brazil and China that included 400 and 422 senior citizens, respectively, showed that elderly recipients of the vaccine exhibited only mild to moderate side effects.

“Sinovac has a good safety profile and the side effects only range from mild to moderate,” she said.

Gloriani herself has been vaccinated with two doses of Sinovac already, having signed a waiver since the FDA’s existing emergency use authorization on Sinovac only recommended it for clinically healthy individuals aged 18 to 59 years old.

Gloriani said getting the Sinovac shot provides more benefits than harm.

“While Sinovac’s efficacy on elderly is a bit lower due to low number of elderly participants in the clinical trials, the same clinical trials still showed that Sinovac can still prevent elderly from getting a severe COVID-19,” she said in Filipino.

Gloriani urged seniors to get their COVID-19 vaccine as soon as it is offered to them, including Sinovac.

“We cannot wait for too long,” she said.

The Department of Health (DOH) on Wednesday said it hoped a delayed shipment of COVID-19 vaccines from AstraZeneca would arrive by the end of May so that those who have already received a first jab can get their second dose.

In a press briefing Wednesday, Health Undersecretary Maria Rosario Vergeire said the World Health Organization (WHO) had informed the Philippines of the delay in the delivery of AstraZeneca vaccines from the COVAX Facility it leads.

The WHO did not say when the vaccines would finally arrive, but Vergeire said this was not a cause for concern to those who have already received their first dose, as the interval between the first and second jab can be extended for 12 weeks.

She added that some studies show that the efficacy of the vaccine could be even higher if the interval between the first and second shot is longer.

Last week, the DOH said 979,200 doses of AstraZeneca’s COVID-19 vaccine initially expected this month will arrive in the country in April or early May.

However, vaccine czar Carlito Galvez Jr. on Tuesday said there would be a “slight delay” in the delivery of COVID-19 vaccines from the COVAX Facility due to logistical problems.

The supply problems stem in part from India’s decision to temporarily stop exports of AstraZeneca so that the vaccines can be used there.

India, one of the world’s largest producers of COVID-19 vaccines, supplies millions of AstraZeneca doses to the WHO-led COVAX Facility, which seeks to ensure the equitable distribution of COVID-19 vaccines.

The Philippines has so far received 2.5 million doses of COVID-19 vaccines, with the bulk coming from Chinese company Sinovac Biotech. Only 525,600 were from AstraZeneca through the COVAX Facility.

AstraZeneca was approved by the FDA for use on senior citizens.

AstraZeneca has been favored by some groups over other vaccine brands due to its regular storage requirements and lower price.

Its longer interval for its second dose also allows countries to vaccinate as many people as possible without the need for immediately securing supplies for the second dose.

The Philippines, which aims to inoculate up to 70 million Filipinos by the end of the year to reach herd immunity against the coronavirus, has been criticized for its slow rollout of vaccines as COVID-19 cases surge in Metro Manila and nearby areas.

Party-list Rep. Mike Defensor, who is pushing for the use of ivermectin — an unauthorized and unproven anti-parasite drug normally used for animals — as a COVID-19 treatment, asked the government to explain what would happen to those who had already been given the first dose of the AstraZeneca vaccine.

“I am sure this is also the question many of the more than 500,000 health care workers and senior citizens who chose the British-Swedish vaccine have in mind,” he said.

He said many of the country’s health workers who refused the China-made CoronaVac and chose AstraZeneca received their first dose in the middle of last month.

He pointed out that hundreds of senior citizens and persons with co-morbidities also took AstraZeneca, since CoronaVac was not suited for them.

“If we follow the 28-day dosing interval, they should get their second dose before the end of this month, at the latest. But the second shipment of AstraZeneca is expected to be delivered next month or in June yet because of short supply,” Defensor said.

He called on the DOH to inform those who have been vaccinated what would happen if they don’t get the second dose on time and what is the maximum interval between the two doses.

Also Wednesday, Amnesty International said rich countries are failing a “rudimentary” test of global solidarity by hoarding COVID vaccines and accused China and others of exploiting the pandemic to undermine human rights.

In its annual report, the campaigning rights organization said the health crisis had exposed “broken” policies and that cooperation was the only way forward.

“The pandemic has cast a harsh light on the world’s inability to cooperate effectively and equitably,” said Agnes Callamard, who was appointed Amnesty’s secretary general last month.

“The richest countries have effected a near-monopoly of the world’s supply of vaccines, leaving countries with the fewest resources to face the worst health and human rights outcomes.”

Amnesty strongly criticized the decision by former US president Donald Trump to withdraw Washington from the World Health Organization (WHO) amid the pandemic — a step now reversed by Trump’s successor Joe Biden.

Callamard called for an immediate acceleration of the global vaccine rollout, calling the inoculation campaign “a most fundamental, even rudimentary, test of the world’s capacity for cooperation”. 

Since the coronavirus emerged in China in late 2019, the pandemic has claimed more than 2.8 million lives globally and infected at least 130 million people.

Despite regular calls for global solidarity from international organizations, figures show widening inequality in access to vaccines.

According to a count by the Agence France-Presse, more than half the 680 million-plus doses administered worldwide have been in high-income countries, such as the United States, Britain and Israel, while the poorest have received only 0.1 percent of the doses.

At the end of March, the WHO warned of an increasingly unbalanced distribution of vaccines.

Amnesty International has supported initiatives such as the WHO’s vaccine exchange platform C-TAP to share know-how, intellectual property, and data.

The under-used initiative could be used to build production capacity and additional vaccine production sites, particularly in Africa, Asia, and Latin America, according to the WHO.

Amnesty dismissed as “paltry half-measures” decisions like those of the G20 group of nations to suspend debt repayments for 77 nations.

Amnesty also hit out at the “gross irresponsibility” of China during the pandemic, accusing Beijing of censoring health workers and journalists who tried to sound the alarm at the start of the outbreak.

“COVID-19 intensified a crackdown on freedom of expression with a number of citizen journalists who reported on the outbreak going missing, and in some cases being imprisoned,” it said.

The WHO on Wednesday said the risk-benefit balance for the AstraZeneca Covid-19 vaccine is “still largely positive,” after fresh claims about links to blood clots.

A top official from the European Medicines Agency — the EU’s drug regulator — claimed there was a clear connection between the jab and clots, though the EMA itself said it was still reviewing data and no conclusions had yet been reached.

The WHO said there was no evidence that the risk-benefit analysis had shifted on the jab, which is one of only three different COVID-19 vaccines so far to have received the green light from the UN health agency.

“There is no link for the moment between the vaccine and thrombotic events with thrombocytopenia,” Rogerio Pinto de Sa Gaspar, the WHO’s director for regulation and pre-qualification, told a press conference.

Also Wednesday, the Philippine Pharmacists Association said pharmacists are now allowed to administer COVID-19 vaccines after undergoing training through the Immunizing Pharmacist Certification Program.

The group said the Professional Regulation Commission (PRC) and the Professional Regulatory Board of Pharmacy have accredited the association to train and certify Filipino pharmacists to administer COVID-19 vaccines and other vaccines to adults through the certification program. With AFP

COMMENT DISCLAIMER: Reader comments posted on this Web site are not in any way endorsed by Manila Standard. Comments are views by manilastandard.net readers who exercise their right to free expression and they do not necessarily represent or reflect the position or viewpoint of manilastandard.net. While reserving this publication’s right to delete comments that are deemed offensive, indecent or inconsistent with Manila Standard editorial standards, Manila Standard may not be held liable for any false information posted by readers in this comments section.

Source link

SHARE ME PLEASE!
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  

Leave a Reply