FDA to complete evaluation of J&J’s COVID-19 vaccine this week
The Food and Drug Administration (FDA) expects to complete its evaluation of Johnson & Johnson’s Janssen COVID-19 vaccine within this week following its application for an emergency use authorization (EUA), the FDA chief said on Monday.
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President Rodrigo
Roa Duterte presides over a meeting with the Inter-Agency Task Force on the
Emerging Infectious Diseases (IATF-EID) core members prior to his talk to the
people at the MalacaΓ±ang Golf (Malago) Clubhouse in MalacaΓ±ang Park, Manila on
April 12, 2021. KING RODRIGUEZ/ PRESIDENTIAL PHOTO
In the
case of China’s Sinopharm, Domingo said somebody sent them a letter conveying
the drugmaker’s intention to apply for an EUA but it is yet to comply the
requirements of the FDA.
America’s
Moderna, on the other hand, is still completing its documents and its local
partner will submit them hopefully this week, according to Domingo.
“Iyong
Moderna mayroon na rin po ‘yang EUA sa US at saka sa European Union so hindi
naman po tayo matatagalan sa pag-evaluate po niyan. Medyo nagbabasa-basa na nga
po tayo, ‘yong ating mga evaluators kahit wala pa pong submission,” he told the
President.
Domingo
also said they expect Novavax to apply after the second quarter. There is still
no EUA issued on Novavax elsewhere and it appears that the drugmaker will apply
in May or June.
In the
Philippines, the company may possibly apply for an EUA towards the later part
of the year, the FDA head said.
Pharmaceutical
companies which were granted EUA include Pfizer Inc., AstraZeneca, Sinovac, and
Gamaleya Research Institute. A fifth drugmaker, Bharat Biotech from India has a
pending application.
Domingo
also reported on the supply the COVID-19 therapeutic drugs. Because of the
surge in cases, there is difficulty in the distribution of Remdesivir in
hospitals.
But
Domingo said suppliers have made an assurance that there is availability of
stocks for at least one month and importations are ongoing. Hospitals secure
compassionate special permit from the FDA for Remdesivir so that they could
administer the drug to their patients.
In the
case of Avigan, Domingo said there is enough supply of the drug, which is
usually given to mild and moderate COVID-19 cases. Hospitals also has to apply
for compassionate special permit for Avigan since the drug is not yet fully
registered in the Philippines.
Tocilizumab,
another therapeutic drug, is in short supply this week because there is only
one manufacturer and supplier for the drug, according to Domingo.
“It’s a
patented drug at although ang magandang balita naman po, kanina nag-email na po
'yong supplier nito at may padating na po daw sila na 5,000 doses sa Pilipinas
this week so this will be distributed to the hospitals. This is a registered
drug so wala pong problema ito. Mayroon po itong CPR,” he said.
Also in
his report, Domingo said Ivermectin is not yet included in the treatment
protocol being followed by Department of Health (DOH) as well as by the
Infectious disease specialists.
Although
the drug is approved for animal use, Domingo said three companies signified
their intention to register Ivermectin so that it could be administered to
humans.
“Binigyan
na po namin sila ng listahan ng requirements at basta naman po sila mag-submit
eh ie-evaluate naman po agad ito ng FDA,” he said. PND
